Anti-tachycardia pacing control in an implantable medical device system

ABSTRACT

An implantable medical device system is configured to detect a tachyarrhythmia from a cardiac electrical signal and start an ATP therapy delay period. The implantable medical device determines whether the cardiac electrical signal received during the ATP therapy delay period satisfies ATP delivery criteria. A therapy delivery module is controlled to cancel the delayed ATP therapy if the ATP delivery criteria are not met and deliver the delayed ATP therapy if the ATP delivery criteria are met.

TECHNICAL FIELD

The disclosure relates generally to an implantable medical device systemand method for delaying anti-tachycardia pacing (ATP) therapy anddetermining whether to deliver or cancel the delayed ATP therapy basedon ATP delivery criteria.

BACKGROUND

Medical devices, such as cardiac pacemakers and ICDs, providetherapeutic electrical stimulation to a heart of a patient viaelectrodes carried by one or more medical electrical leads and/orelectrodes on a housing of the medical device. The electricalstimulation may include signals such as pacing pulses or cardioversionor defibrillation shocks. In some cases, a medical device may sensecardiac electrical signals attendant to the intrinsic or pacing-evokeddepolarizations of the heart and control delivery of stimulation signalsto the heart based on sensed cardiac electrical signals. Upon detectionof an abnormal rhythm, such as bradycardia, tachycardia or fibrillation,an appropriate electrical stimulation signal or signals may be deliveredto restore or maintain a more normal rhythm of the heart. For example,an ICD may deliver pacing pulses to the heart of the patient upondetecting bradycardia or tachycardia or deliver cardioversion ordefibrillation shocks to the heart upon detecting tachycardia orfibrillation. An extra-cardiovascular ICD system utilizes therapydelivery electrodes located outside the cardiovascular system, whichavoids having to introduce implantable leads and electrodes within thepatient's bloodstream. Electrical stimulation therapies that aredelivered using extra-cardiovascular electrodes may require highervoltages in order to be effective compared to electrical stimulationtherapies delivered using electrodes proximate to or in intimate contactwith cardiac tissue, such as endocardial electrodes or epicardialelectrodes.

SUMMARY

In general, the disclosure is directed to techniques for controllingdelivery of ATP to a patient's heart by an implantable medical devicesystem, which may include an extra-cardiovascular ICD in some examples.An implantable medical device system operating according to thetechniques disclosed herein is configured to detect tachyarrhythmia anddelay ATP therapy for a delay period. The system determines if a cardiacelectrical signal satisfies ATP delivery criteria during the delayperiod and cancels the ATP therapy if the delivery criteria are unmet.

In one example, the disclosure provides an implantable medical devicesystem including a sensing module configured to receive a cardiacelectrical signal from a patient's heart and sense cardiac events fromthe cardiac electrical signal; a therapy delivery module configured togenerate pulses for delivering an anti-tachycardia pacing (ATP) therapyto the patient's heart via a pacing electrode vector; and a controlmodule coupled to the sensing module and the therapy delivery module.The control module is configured to detect a tachyarrhythmia from thecardiac electrical signal and start an ATP therapy delay period inresponse to detecting the tachyarrhythmia. The control module determineswhether the cardiac electrical signal received by the sensing moduleduring the ATP therapy delay period satisfies ATP delivery criteria andin response to the ATP delivery criteria being satisfied, controls thetherapy delivery module to deliver the delayed ATP therapy. The controlmodule cancels the delayed ATP therapy in response to the ATP deliverycriteria not being met.

In another example, the disclosure provides a method performed by animplantable medical device system. The method includes detecting atachyarrhythmia from a cardiac electrical signal and staring an ATPtherapy delay period in response to detecting the tachyarrhythmia. Themethod further includes determining whether the cardiac electricalsignal received during the ATP therapy delay period satisfies ATPdelivery criteria, and in response to the ATP delivery criteria beingsatisfied, controlling a therapy delivery module to deliver the delayedATP therapy. The method includes canceling the delayed ATP therapy inresponse to the ATP delivery criteria not being met.

In another example, the disclosure provides a non-transitory,computer-readable storage medium storing a set of instructions which,when executed by a control module of an implantable medical devicesystem cause the system to detect a tachyarrhythmia from a cardiacelectrical signal received by a sensing module from a patient's heart,and, in response to detecting the tachyarrhythmia, starting an ATPtherapy delay period. The system is further caused to determine whetherthe cardiac electrical signal received by the sensing module during theATP therapy delay period satisfies ATP delivery criteria and, inresponse to the ATP delivery criteria being satisfied, control a therapydelivery module to deliver the delayed ATP therapy. The instructionsfurther cause the system to cancel the delayed ATP therapy in responseto the ATP delivery criteria not being met.

This summary is intended to provide an overview of the subject matterdescribed in this disclosure. It is not intended to provide an exclusiveor exhaustive explanation of the apparatus and methods described indetail within the accompanying drawings and description below. Furtherdetails of one or more examples are set forth in the accompanyingdrawings and the description below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are conceptual diagrams of an extra-cardiovascular ICDsystem according to one example.

FIGS. 2A-2C are conceptual diagrams of a patient implanted with theextra-cardiovascular ICD system of FIG. 1A in a different implantconfiguration.

FIG. 3 is a conceptual diagram of a distal portion of anextra-cardiovascular lead having an electrode configuration according toanother example.

FIG. 4 is a conceptual diagram of a distal portion of anextra-cardiovascular lead having a lead body shape according to anotherexample.

FIG. 5 is a schematic diagram of the ICD of the system of FIGS. 1A-2Caccording to one example.

FIG. 6 is schematic diagram of HV therapy module coupled to a processorand HV therapy control module.

FIG. 7 is a flow chart of a method for controlling ATP deliveryaccording to one example.

FIG. 8 is a flow chart of a method for controlling ATP deliveryaccording to another example.

FIG. 9 is a flow chart of a method for adjusting tachyarrhythmiadetection parameters in response to canceling an ATP therapy.

FIG. 10 is a schematic diagram of one example of a transvenous ICDsystem 400 in which aspects disclosed herein for controlling ATP therapymay be implemented.

FIGS. 11A and 11B are a schematic diagrams of an implantable medicaldevice system that includes an extra-cardiovascular ICD and anintra-cardiac pacemaker.

FIG. 12 is a flow chart of a method for controlling ATP therapy by animplantable medical device system according to another example.

FIG. 13 is a flow chart of a method for controlling ATP therapy by animplantable medical device system according to another example.

DETAILED DESCRIPTION

In general, this disclosure describes techniques for controlling ATPdelivery by an implantable medical device system. These techniques maybe implemented in a variety of implantable medical device (IMD) systemscapable of detecting tachyarrhythmia and generating and deliveringelectrical stimulation pulses for terminating the tachyarrhythmia, suchas transvenous ICD systems, ICD systems that include an intra-cardiacpacemaker, and extra-cardiovascular ICD systems.

In some examples, the system includes an extra-cardiovascular ICDconfigured to deliver the ATP using implanted, extra-cardiovascularelectrodes. As used herein, the term “extra-cardiovascular” refers to aposition outside the blood vessels, heart, and pericardium surroundingthe heart of a patient. Implantable electrodes carried byextra-cardiovascular leads may be positioned extra-thoracically (outsidethe ribcage and sternum) or intra-thoracically (beneath the ribcage orsternum) but generally not in intimate contact with myocardial tissue.

In IMD systems that include transvenous leads or an intra-cardiacpacemaker positioning pacing electrodes in contact or intimate proximitywith myocardial tissue, a low voltage therapy module may deliver the ATPpacing pulses. Examples of IMD systems that may deliver ATP therapyusing a low voltage therapy module and according to the techniquesdisclosed herein are shown and described in conjunction with FIGS. 10and 11.

In an extra-cardiovascular ICD system, ATP may be delivered from the LVtherapy module or from a high voltage (HV) therapy module, particularlywhen pacing pulses delivered from the low voltage pacing circuit, whichuses relatively lower voltage capacitors, do not capture the heart.Capture is achieved when the energy of a delivered pulse is greater thana capture threshold and causes a depolarization of the myocardialtissue, often referred to as an “evoked response.” Inextra-cardiovascular ICD systems, the HV therapy module used fordelivering high voltage cardioversion/defibrillation (CV/DF) shocks maybe required for delivering cardiac pacing pulses since the pacingcapture threshold of an extra-cardiovascular pacing electrode vector maybe higher than the pacing pulse energy available from a low voltagepacing therapy module. The HV therapy module of an ICD generallyincludes a HV capacitor that is chargeable to a shock voltage amplitudefor delivering a shock pulse to cardiovert or defibrillate the heart.The HV capacitor may be charged to a pacing voltage amplitude that isless than the shock voltage amplitude for delivering ATP. In someexamples, an ICD configured to control ATP therapy delivery according tothe techniques disclosed herein may deliver ATP pulses via implantedextra-cardiovascular electrodes from a HV therapy module that is alsoused for delivering CV/DF shocks.

FIGS. 1A and 1B are conceptual diagrams of an extra-cardiovascular ICDsystem 10 according to one example. FIG. 1A is a front view of ICDsystem 10 implanted within patient 12. FIG. 1B is a side view of aportion of ICD system 10 implanted within patient 12. ICD system 10includes an ICD 14 connected to an extra-cardiovascular electricalstimulation and sensing lead 16. FIGS. 1A and 1B are described in thecontext of an ICD system 10 capable of providing defibrillation and/orcardioversion shocks and cardiac pacing pulses.

ICD 14 includes a housing 15 that forms a hermetic seal that protectsinternal components of ICD 14. The housing 15 of ICD 14 may be formed ofa conductive material, such as titanium or titanium alloy. The housing15 may function as a housing electrode (sometimes referred to as a “can”electrode). In examples described herein, housing 15 may be used as anactive can electrode for use in delivering high voltage CV/DF shocks andrelatively lower voltage cardiac pacing pulses generated by a highvoltage therapy module. The housing 15 of ICD 14 may include a pluralityof electrodes on an outer portion of the housing instead of acting as asingle electrode. The outer portion(s) of the housing 15 functioning asan electrode(s) may be coated with a material, such as titanium nitride,e.g., for reducing polarization artifact.

ICD 14 includes a connector assembly 17 (also referred to as a connectorblock or header) that includes electrical feedthroughs crossing housing15 to provide electrical connections between conductors extending withinan elongated lead body 18 of lead 16 and electronic components includedwithin the housing 15 of ICD 14. As will be described in further detailherein, housing 15 may house one or more processors, memories,transceivers, sensors, electrical signal sensing circuitry, therapydelivery circuitry, power sources and other appropriate components.

Elongated lead body 18 includes a proximal end 27 that includes a leadconnector (not shown) configured to be connected to ICD connectorassembly 17 and a distal portion 25 that includes one or moreelectrodes. In the example illustrated in FIGS. 1A and 1B, the distalportion 25 of lead 16 includes defibrillation electrodes 24A and 24B,collectively 24, and pace/sense electrodes 28A, 28B, and 30. In somecases, defibrillation electrodes 24A and 24B may together form adefibrillation electrode in that they are configured to be activatedconcurrently. Alternatively, defibrillation electrodes 24A and 24B mayform separate defibrillation electrodes in which case each of theelectrodes 24A and 24B may be activated independently. In someinstances, defibrillation electrodes 24A and 24B are coupled toelectrically isolated conductors, and ICD 14 may include switchingmechanisms to allow electrodes 24A and 24B to be utilized as a singledefibrillation electrode (e.g., activated concurrently to form a commoncathode or anode) or as separate defibrillation electrodes, (e.g.,activated individually, one as a cathode and one as an anode oractivated one at a time, one as an anode or cathode and the otherremaining inactive with housing 15 as an active electrode).

Electrodes 24A and 24B (and in some example housing 15) are referred toas defibrillation electrodes because they are utilized, individually orcollectively, for delivering high voltage stimulation shocks (e.g.,cardioversion or defibrillation shocks). Electrodes 24A and 24B may beelongated coil electrodes and generally have a relatively high surfacearea for delivering high voltage electrical stimulation shocks comparedto low voltage pacing and sensing electrodes. However, electrodes 24Aand 24B and housing 15 may also be utilized to provide pacingfunctionality, sensing functionality or both pacing and sensingfunctionality in addition to or instead of high voltage shocks. In thissense, the use of the term “defibrillation electrode” herein should notbe considered as limiting the electrodes 24A and 24B to use in only highvoltage CV/DF shock delivery. As described herein, electrodes 24A and/or24B may be used in a pacing electrode vector for deliveringextra-cardiovascular pacing pulses from a high-voltage therapy modulethat is also used for delivering CV/DF shocks.

Electrodes 28A, 28B and 30 are relatively smaller surface areaelectrodes for delivering relatively low voltage pacing pulses and forsensing cardiac electrical signals. Electrodes 28A, 28B and 30 arereferred to as pace/sense electrodes because they are generallyconfigured for use in low voltage applications, e.g., used as either acathode or anode for delivery of pacing pulses and/or sensing of cardiacelectrical signals. In some instances, electrodes 28A, 28B, and 30 mayprovide only pacing functionality, only sensing functionality or both.

In the example illustrated in FIGS. 1A and 1B, electrodes 28A and 28Bare located between defibrillation electrodes 24A and 24B and electrode30 is located distal to defibrillation electrode 24A. Electrodes 28A and28B are illustrated as ring electrodes, and electrode 30 is illustratedas a hemispherical tip electrode in the example of FIGS. 1A and 1B.However, electrodes 28A, 28B, and 30 may comprise any of a number ofdifferent types of electrodes, including ring electrodes, short coilelectrodes, paddle electrodes, hemispherical electrodes, directionalelectrodes, segmented electrodes, or the like, and may be positioned atany position along the distal portion 25 of lead 16. Further, electrodes28A, 28B, and 30 may be of similar type, shape, size and material or maydiffer from each other.

Lead 16 extends subcutaneously or submuscularly over the ribcage 32medially from the connector assembly 27 of ICD 14 toward a center of thetorso of patient 12, e.g., toward xiphoid process 20 of patient 12. At alocation near xiphoid process 20, lead 16 bends or turns and extendssuperior subcutaneously or submuscularly over the ribcage and/orsternum, substantially parallel to sternum 22. Although illustrated inFIGS. 1A and 1B as being offset laterally from and extendingsubstantially parallel to sternum 22, lead 16 may be implanted at otherlocations, such as over sternum 22, offset to the right or left ofsternum 22, angled laterally from sternum 22 toward the left or theright, or the like. Alternatively, lead 16 may be placed along othersubcutaneous or submuscular paths. The path of lead 16 may depend on thelocation of ICD 14 or other factors.

Electrical conductors (not illustrated) extend through one or morelumens of the elongated lead body 18 of lead 16 from the lead connectorat the proximal lead end 27 to respective electrodes 24A, 24B, 28A, 28B,and 30 located along the distal portion 25 of the lead body 18. Leadbody 18 may be tubular or cylindrical in shape. In other examples, thedistal portion 25 (or all of) the elongated lead body 18 may have aflat, ribbon or paddle shape. The lead body 18 of lead 16 may be formedfrom a non-conductive material, including silicone, polyurethane,fluoropolymers, mixtures thereof, and other appropriate materials, andshaped to form one or more lumens within which the one or moreconductors extend. However, the techniques disclosed herein are notlimited to such constructions or to any particular lead body design.

The elongated electrical conductors contained within the lead body 18electrically couple the electrodes 24A, 24B, 28A, 28B and 30 tocircuitry, such as a therapy module and/or a sensing module, of ICD 14via connections in the connector assembly 17, including associatedelectrical feedthroughs crossing housing 15. The electrical conductorstransmit therapy from a therapy module within ICD 14 to one or more ofdefibrillation electrodes 24A and 24B and/or pace/sense electrodes 28A,28B, and 30 and transmit sensed electrical signals from one or more ofdefibrillation electrodes 24A and 24B and/or pace/sense electrodes 28A,28B, and 30 to the sensing module within ICD 14.

FIGS. 1A and 1B are illustrative in nature and should not be consideredlimiting of the practice of the techniques disclosed herein. In otherexamples, lead 16 may include less than three pace/sense electrodes ormore than three pace/sense electrodes and/or a single defibrillationelectrode or more than two electrically isolated or electrically coupleddefibrillation electrodes or electrode segments. The pace/senseelectrodes 28A, 28B, and 30 may be located elsewhere along the length oflead 16, e.g., distal to defibrillation electrode 24A, proximal todefibrillation electrode 24B, and/or between electrodes 24A and 24B. Forexample, lead 16 may include a single pace/sense electrode 28 betweendefibrillation electrodes 24A and 24B and no pace/sense electrode distalto defibrillation electrode 24A or proximal to defibrillation electrode24B.

In other examples, lead 16 may include only a single pace/senseelectrode 28 between defibrillation electrodes 24A and 24B and includeanother discrete electrode(s) distal to defibrillation electrode 24Aand/or proximal to defibrillation electrode 24B. Various exampleconfigurations of extra-cardiovascular leads and electrodes anddimensions that may be implemented in conjunction with theextra-cardiovascular pacing techniques disclosed herein are described incommonly-assigned U.S. Pat. Publication No. 2015/0306375 (Marshall, etal.) and U.S. Pat. Publication No. 2015/0306410 (Marshall, et al.), bothof which are incorporated herein by reference in their entirety.

In still other examples, ICD system 10 of FIGS. 1A and 1B may include asecond extra-cardiovascular electrical stimulation and sensing leadsimilar to lead 16. The second lead may, for example, extend laterallyto the posterior of patient 12 and include one or more electrodes thatform an electrode vector with one or more of electrodes 24A, 24B, 28A,28B, and/or 30 of lead 16 for providing cardiac pacing in accordancewith the techniques disclosed herein.

ICD 14 is shown implanted subcutaneously on the left side of patient 12along the ribcage 32. ICD 14 may, in some instances, be implantedbetween the left posterior axillary line and the left anterior axillaryline of patient 12. ICD 14 may, however, be implanted at othersubcutaneous or submuscular locations in patient 12. For example, ICD 14may be implanted in a subcutaneous pocket in the pectoral region. Inthis case, lead 16 may extend subcutaneously or submuscularly from ICD14 toward the manubrium of sternum 22 and bend or turn and extendinferior from the manubrium to the desired location subcutaneously orsubmuscularly. In yet another example, ICD 14 may be placed abdominally.Lead 16 may be implanted in other extra-cardiovascular locations aswell. For instance, as described with respect to FIGS. 2A-2C, the distalportion 25 of lead 16 may be implanted underneath the sternum/ribcage inthe substernal space.

In some instances, electrodes 24A, 24B, 28A, 28B, and/or 30 of lead 16may be shaped, oriented, designed or otherwise configured to reduceextra-cardiac stimulation. For example, electrodes 24A, 24B, 28A, 28B,and/or 30 of lead 16 may be shaped, oriented, designed, partiallyinsulated or otherwise configured to focus, direct or point electrodes24A, 24B, 28A, 28B, and/or 30 toward heart 26. In this manner,electrical stimulation pulses delivered via lead 16 are directed towardheart 26 and not outward toward skeletal muscle. For example, electrodes24A, 24B, 28A, 28B, and/or 30 of lead 16 may be partially coated ormasked with a polymer (e.g., polyurethane) or another coating material(e.g., tantalum pentoxide) on one side or in different regions so as todirect the electrical energy toward heart 26 and not outward towardskeletal muscle. In the case of a ring electrode, for example, the ringelectrode may be partially coated with the polymer or other material toform a half-ring electrode, quarter-ring electrode, or otherpartial-ring electrode. When ICD 14 delivers pacing pulses viaelectrodes 24A, 24B, 28A, 28B, and/or 30, recruitment of surroundingskeletal muscle by the pacing pulses, which may cause discomfort to thepatient, may be reduced by shaping, orienting, or partially insulatingelectrodes 24 to focus or direct electrical energy toward heart 26.

ICD 14 may obtain electrical signals corresponding to electricalactivity of heart 26 via one or more sensing electrode vectors thatinclude a combination of electrodes 28A, 28B, and 30 and the housing 15of ICD 14. For example, ICD 14 may obtain cardiac electrical signalssensed using a sensing vector between combinations of electrodes 28A,28B, and 30 with one another or obtain cardiac electrical signals usinga sensing vector between any one or more of electrodes 28A, 28B, and 30and the conductive housing 15 of ICD 14. In some instances, ICD 14 mayeven obtain cardiac electrical signals using a sensing vector thatincludes one or both defibrillation electrodes 24A or 24B such asbetween each other or in combination with one or more of electrodes 28A,28B, and 30, and/or the housing 15.

ICD 14 analyzes the cardiac electrical signals received from one or moreof the sensing vectors to monitor for abnormal rhythms, such asbradycardia, ventricular tachycardia (VT) or ventricular fibrillation(VF), for detecting a need for cardiac pacing or a CV/DF shock. ICD 14may analyze the heart rate and/or morphology of the cardiac electricalsignals to monitor for tachyarrhythmia in accordance with any of anumber of tachyarrhythmia detection techniques. One example techniquefor detecting tachyarrhythmia is described in U.S. Pat. No. 7,761,150(Ghanem, et al.), incorporated by reference herein in its entirety.

ICD 14 generates and delivers electrical stimulation therapy in responseto detecting a tachyarrhythmia (e.g., VT or VF). ICD 14 may deliver oneor more CV/DF shocks via one or both of defibrillation electrodes 24Aand 24B and/or housing 15 if VT or VF is detected. In some therapyprotocols anti-tachycardia pacing (ATP) pulses are delivered prior to aCV/DF shock in response to detecting VT or VF and may terminate thetachyarrhythmia, precluding the need for a shock.

ATP pulses may be delivered using an electrode vector that includes oneor more of the electrodes 24A, 24B, 28A, 28B and/or 30, and/or thehousing 15 of ICD 14. As described below, ICD 14 may be configured todeliver cardiac pacing pulses from a high voltage (HV) therapy moduleand may control the high voltage therapy module to deliver ATP afterpreparing the HV therapy module for delivering the ATP and confirmingthat ATP delivery criteria are met.

An external device 40 is shown in telemetric communication with ICD 14by a communication link 42. External device 40 may include a processor,display, user interface, telemetry unit and other components forcommunicating with ICD 14 for transmitting and receiving data viacommunication link 42. Communication link 42 may be established betweenICD 14 and external device 40 using a radio frequency (RF) link such asBLUETOOTH®, Wi-Fi, or Medical Implant Communication Service (MICS) orother RF or communication frequency bandwidth.

External device 40 may be embodied as a programmer used in a hospital,clinic or physician's office to retrieve data from ICD 14 and to programoperating parameters and algorithms in ICD 14 for controlling ICDfunctions. External device 40 may be used to program cardiac rhythmdetection parameters and therapy control parameters used by ICD 14.Control parameters used to generate and deliver cardiac electricalstimulation pulses according to techniques disclosed herein, includingATP protocols, may be programmed into ICD 14 using external device 40.

Data stored or acquired by ICD 14, including physiological signals orassociated data derived therefrom, results of device diagnostics, andhistories of detected rhythm episodes and delivered therapies, may beretrieved from ICD 14 by external device 40 following an interrogationcommand. For example, pacing capture threshold tests may be initiated bya user interacting with external device 40. A user may observe cardiacelectrical signals retrieved from ICD 14 on a display of external device40 for confirming cardiac capture by pacing pulses delivered by ICD 14during a capture threshold test. External device 40 may alternatively beembodied as a home monitor or hand held device.

FIGS. 2A-2C are conceptual diagrams of patient 12 implanted with ICDsystem 10 in a different implant configuration than the arrangementshown in FIGS. 1A-1B. FIG. 2A is a front view of patient 12 implantedwith ICD system 10. FIG. 2B is a side view of patient 12 implanted withICD system 10. FIG. 2C is a transverse view of patient 12 implanted withICD system 10. In this arrangement, lead 16 of system 10 is implanted atleast partially underneath sternum 22 of patient 12. Lead 16 extendssubcutaneously or submuscularly from ICD 14 toward xiphoid process 20and at a location near xiphoid process 20 bends or turns and extendssuperiorly within anterior mediastinum 36 in a substernal position.

Anterior mediastinum 36 may be viewed as being bounded laterally bypleurae 39, posteriorly by pericardium 38, and anteriorly by sternum 22.In some instances, the anterior wall of anterior mediastinum 36 may alsobe formed by the transversus thoracis muscle and one or more costalcartilages. Anterior mediastinum 36 includes a quantity of looseconnective tissue (such as areolar tissue), adipose tissue, some lymphvessels, lymph glands, substernal musculature, small side branches ofthe internal thoracic artery or vein, and the thymus gland. In oneexample, the distal portion 25 of lead 16 extends along the posteriorside of sternum 22 substantially within the loose connective tissueand/or substernal musculature of anterior mediastinum 36.

A lead implanted such that the distal portion 25 is substantially withinanterior mediastinum 36 may be referred to as a “substernal lead.” Inthe example illustrated in FIGS. 2A-2C, lead 16 is located substantiallycentered under sternum 22. In other instances, however, lead 16 may beimplanted such that it is offset laterally from the center of sternum22. In some instances, lead 16 may extend laterally such that distalportion 25 of lead 16 is underneath/below the ribcage 32 in addition toor instead of sternum 22. In other examples, the distal portion 25 oflead 16 may be implanted in other extra-cardiovascular, intra-thoraciclocations, including the pleural cavity or around the perimeter of andadjacent to but typically not within the pericardium 38 of heart 26.Other implant locations and lead and electrode arrangements that may beused in conjunction with the cardiac pacing techniques described hereinare generally disclosed in the above-incorporated references. Althoughexample extra-cardiovascular locations are described above with respectto FIGS. 1A, 1B and 2A-2C, the cardiac pacing techniques of thisdisclosure may be utilized in other implementations ofextra-cardiovascular pacing applications.

FIG. 3 is a conceptual diagram illustrating a distal portion 25′ ofanother example of implantable electrical lead 16 having an alternativeelectrode arrangement. In this example, distal portion 25′ includes twopace/sense electrodes 28A and 28B and two defibrillation electrodes 24Aand 24B and respective conductors (not shown) to provide the electricalstimulation and sensing functionality as described above in conjunctionwith FIGS. 1A, 1B and FIGS. 2A-2C. In this example, however, electrode28B is proximal to proximal defibrillation electrode 24B, and electrode28A is distal to proximal defibrillation electrode 24B such thatelectrodes 28A and 28B are separated by defibrillation electrode 24B. Ina further example, in addition to electrodes 28A and 28B, lead 16 mayinclude a third pace/sense electrode located distal to defibrillationelectrode 24A.

The spacing and location of pace/sense electrodes 28A and 28B may beselected to provide pacing vectors that enable efficient pacing of heart26. The lengths and spacing of electrodes 24A, 24B, 28A and 28B maycorrespond to any of the examples provided in the above-incorporatedreferences. For example, the distal portion 25′ of lead 16 from thedistal end to the proximal side of the most proximal electrode (e.g.,electrode 28B in the example of FIG. 3) may be less than or equal to 15cm and may be less than or equal to 13 cm and or even less than or equalto 10 cm. The spacing and location of pace/sense electrodes 28A and 28Bmay be selected to provide pacing vectors that enable efficient pacingof heart 26. It is contemplated that one or more pace/sense electrodesmay be distal to distal defibrillation electrode 24A, one or morepace/sense electrodes may be between defibrillation electrodes 24A and24B, and/or one or more pace/sense electrodes may be proximal toproximal defibrillation electrode 24B. Having multiple pace/senseelectrodes at different locations along lead body 18 enables selectionfrom among a variety of inter-electrode spacings, which allows a pacingelectrode pair (or combination) to be selected having an inter-electrodespacing that results in the greatest pacing efficiency.

ICD 14 may deliver electrical stimulation and/or sense electricalsignals using any electrode vector that includes defibrillationelectrodes 24A and 24B (individually or collectively), and/or electrodes28A and/or 28B, and/or the housing 15 of ICD 14. As disclosed herein,ATP may be delivered from a HV therapy module in response to detecting atachyarrhythmia. The ATP may be delivered via a pacing electrode vectorselected from the extra-cardiovascular electrodes 24A, 24B, 28A, 28B, 30and housing 15. The pacing electrode vector for ATP delivery from the HVtherapy module may be between the defibrillation electrodes 24A and 24B,one as the anode and one as the cathode, or between one or both ofdefibrillation electrodes 24A and 24B as a cathode (or anode) and thehousing 15 of ICD 14 as an anode (or cathode). In some cases, apace/sense electrode 28A, 28B, and/or 30 may be included in a pacingelectrode vector used to deliver ATP generated by the HV therapy moduleas described herein.

FIG. 4 is a conceptual diagram illustrating a distal portion 25″ ofanother example of extra-cardiovascular lead 16 having an electrodearrangement similar to that of FIG. 3 but with a non-linear or curvingdistal portion 25″ of lead body 18′. Lead body 18′ may be pre-formed tohave a normally curving, bending, serpentine, undulating, or zig-zaggingshape along distal portion 25″. In this example, defibrillationelectrodes 24A′ and 24B′ are carried along pre-formed curving portionsof the lead body 18′. Pace/sense electrode 28A′ is carried betweendefibrillation electrodes 24A′ and 24B′. Pace/sense electrode 28B′ iscarried proximal to the proximal defibrillation electrode 24B′.

In one example, lead body 18′ may be formed having a normally curvingdistal portion 25″ that includes two “C” shaped curves, which togethermay resemble the Greek letter epsilon, “c.” Defibrillation electrodes24A′ and 24B′ are each carried by the two respective C-shaped portionsof the lead body distal portion 25″ and extend or curve in the samedirection. In the example shown, pace/sense electrode 28A′ is proximalto the C-shaped portion carrying electrode 24A′, and pace/senseelectrode 28B′ is proximal to the C-shaped portion carrying electrode24B′. Pace/sense electrodes 24A′ and 24B′ are approximately aligned witha central axis 31 of the normally straight or linear, proximal portionof lead body 18′ such that mid-points of defibrillation electrodes 24A′and 24B′ are laterally offset from electrodes 28A′ and 28B′.Defibrillation electrodes 24A′ and 24B′ are located along respectiveC-shaped portions of the lead body distal portion 25″ that extendlaterally in the same direction away from central axis 31 and electrodes28A′ and 28B′. Other examples of extra-cardiovascular leads includingone or more defibrillation electrodes and one or more pacing and sensingelectrodes carried by curving serpentine, undulating or zig-zaggingdistal portion of the lead body that may be implemented with the pacingtechniques described herein are generally disclosed in pending U.S. Pat.Publication No. 2016/0158567 (Marshall, et al.), incorporated herein byreference in its entirety.

FIG. 5 is a schematic diagram of ICD 14 according to one example. Theelectronic circuitry enclosed within housing 15 (shown schematically asa can electrode in FIG. 5) includes software, firmware and hardware thatcooperatively monitor one or more cardiac electrical signals, determinewhen a pacing therapy is necessary, and deliver prescribed pacingtherapies as needed. The software, firmware and hardware are alsoconfigured to determine when a CV/DF shock is necessary, and deliverprescribed CV/DF shock therapies. ICD 14 is coupled to anextra-cardiovascular lead, such as lead 16 carrying extra-cardiovascularelectrodes 24A, 24B, 28A, 28B and 30, for delivering pacing therapies,CV/DF shock therapies and sensing cardiac electrical signals.

ICD 14 includes a control module 80, memory 82, therapy delivery module84, electrical sensing module 86, and telemetry module 88. ICD 14 mayinclude an impedance measurement module 90 for delivering a drive signalacross a therapy delivery electrode vector and measuring a resultingvoltage for determining an electrical impedance of the electrode vector.

A power source 98 provides power to the circuitry of ICD 14, includingeach of the modules 80, 82, 84, 86, 88, 90 as needed. Power source 98may include one or more energy storage devices, such as one or morerechargeable or non-rechargeable batteries. The connections betweenpower source 98 and each of the other modules 80, 82, 84, 86 and 88 areto be understood from the general block diagram of FIG. 3, but are notshown for the sake of clarity. For example, power source 98 is coupledto low voltage (LV) and HV charging circuits included in therapydelivery module 84 for charging LV and HV capacitors, respectively, orother energy storage devices included in therapy delivery module 84 forproducing electrical stimulation pulses.

The functional blocks shown in FIG. 5 represent functionality includedin ICD 14 of system 10 but are also representative of the functionalitythat may be included in other IMD systems, such as the systems 400 and500 shown in the FIGS. 10 and 11 respectively, operating according tothe techniques disclosed herein for controlling ATP therapy. In some IMDsystems, such as the system 500 shown in FIGS. 11A and 11B whichincludes both an ICD 14 and an intra-cardiac pacemaker 512, thefunctionality represented by the modules shown in FIG. 5 may bedistributed across more than one implantable medical device included inthe IMD system. The functional blocks and modules shown in FIG. 5 mayinclude any discrete and/or integrated electronic circuit componentsthat implement analog and/or digital circuits capable of producing thefunctions attributed to ICD 14 herein. As used herein, the term “module”refers to an application specific integrated circuit (ASIC), anelectronic circuit, a processor (shared, dedicated, or group) and memorythat execute one or more software or firmware programs, a combinationallogic circuit, state machine, or other suitable components that providethe described functionality. The particular form of software, hardwareand/or firmware employed to implement the functionality disclosed hereinwill be determined primarily by the particular system architectureemployed in the device and by the particular detection and therapydelivery methodologies employed by the IMD system. Providing software,hardware, and/or firmware to accomplish the described functionality inthe context of any modern IMD system, given the disclosure herein, iswithin the abilities of one of skill in the art.

Memory 82 may include any volatile, non-volatile, magnetic, orelectrical non-transitory computer readable storage media, such as arandom access memory (RAM), read-only memory (ROM), non-volatile RAM(NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory,or any other memory device. Furthermore, memory 82 may includenon-transitory computer readable media storing instructions that, whenexecuted by one or more processing circuits, cause control module 80 orother ICD modules to perform various functions attributed to ICD 14 orthose ICD modules. The non-transitory computer-readable media storingthe instructions may include any of the media listed above.

Depiction of different features as modules is intended to highlightdifferent functional aspects and does not necessarily imply that suchmodules must be realized by separate hardware or software components.Rather, functionality associated with one or more modules may beperformed by separate hardware, firmware or software components, orintegrated within common hardware, firmware or software components. Forexample, cardiac pacing operations may be performed by therapy deliverymodule 84 under the control of control module 80 and may includeoperations implemented in a processor executing instructions stored inmemory 82.

Control module 80 communicates with therapy delivery module 84 andelectrical sensing module 86 for sensing cardiac electrical activity,detecting cardiac rhythms, and controlling delivery of cardiacelectrical stimulation therapies in response to sensed cardiac signals.Therapy delivery module 84 and electrical sensing module 86 areelectrically coupled to electrodes 24A, 24B, 28A, 28B, and 30 carried bylead 16 (shown in FIGS. 1A and 1B) and the housing 15, which mayfunction as a common or ground electrode or as an active can electrodefor delivering CV/DF shock pulses.

Electrical sensing module 86 may be selectively coupled to electrodes28A, 28B, 30 and housing 15 in order to monitor electrical activity ofthe patient's heart. Electrical sensing module 86 may additionally beselectively coupled to electrodes 24A and/or 24B. Sensing module 86 mayinclude switching circuitry for selecting which of electrodes 24A, 24B,28A, 28B, 30 and housing 15 are coupled to sense amplifiers or othercardiac event detection circuitry included in sensing module 86.Switching circuitry may include a switch array, switch matrix,multiplexer, or any other type of switching device suitable toselectively couple sense amplifiers to selected electrodes. The cardiacevent detection circuitry within electrical sensing module 86 mayinclude one or more sense amplifiers, filters, rectifiers, thresholddetectors, comparators, analog-to-digital converters (ADCs), or otheranalog or digital components.

In some examples, electrical sensing module 86 includes multiple sensingchannels for acquiring cardiac electrical signals from multiple sensingvectors selected from electrodes 24A, 24B, 28A, 28B, 30 and housing 15.Each sensing channel may be configured to amplify, filter and rectifythe cardiac electrical signal received from selected electrodes coupledto the respective sensing channel to improve the signal quality forsensing cardiac events, e.g., P-waves and/or R-waves. Each sensingchannel includes cardiac event detection circuitry for sensing cardiacevents from the received cardiac electrical signal developed across theselected sensing electrode vector(s). For example, each sensing channelin sensing module 86 may include an input or pre-filter and amplifierfor receiving a cardiac electrical signal from a respective sensingvector, an analog-to-digital converter, a post-amplifier and filter, arectifier to produce a digitized, rectified and amplified cardiacelectrical signal that is passed to a cardiac event detector included insensing module 86 and/or to control module 80. The cardiac eventdetector may include a sense amplifier, comparator or other circuitryfor comparing the rectified cardiac electrical signal to a cardiac eventsensing threshold, such as an R-wave sensing threshold, which may be anauto-adjusting threshold. Sensing module 84 may produce a sensed cardiacevent signal in response to a sensing threshold crossing. The sensedcardiac events, e.g., R-waves, are used for detecting cardiac rhythmsand determining a need for therapy by control module 80. In someexamples, cardiac electrical signals such as sensed R-waves are used todetect capture of a pacing pulse delivered by ICD 14.

Control module 80 is configured to analyze signals received from sensingcircuit 86 for detecting tachyarrhythmia episodes. In some examples, thetiming of R-wave sense event signals received from sensing circuit 86 isused control module 80 to determine RR intervals (RRIs) betweenconsecutive R-wave sensed event signals. Control module 80 may includecomparators and counters for counting RRIs that fall into various ratedetection zones for determining a ventricular rate or performing otherrate- or interval-based assessment for detecting and discriminating VTand VF.

For example, control module 80 may compare the RRIs to one or moretachyarrhythmia detection interval zones, such as a tachycardiadetection interval zone, which may be divided into slow and fasttachycardia detection interval zones, and a fibrillation detectioninterval zone. RRIs falling into a detection interval zone are countedby a respective VT interval counter or VF interval counter and in somecases in a combined VT/VF interval counter included in control module80. When an interval counter reaches a detection threshold, sometimesreferred to as a “number of intervals to detect” or “NID,” a ventriculartachyarrhythmia may be detected by control module 80. Control module 80may be configured to perform other signal analysis for determining ifother detection criteria are satisfied before detecting VT or VF, suchas R-wave morphology criteria, onset criteria, and/or noise oroversensing rejection criteria.

In some patients, detection and therapies for both VT and VF may beenabled. In other patients, VF detection and therapies may be enabledbut VT detection and therapies may be disabled. ATP therapy may beenabled for delivery following detection in either or both of thesesituations. The techniques disclosed herein for controlling ATP therapymay be employed following VT and/or VF detection according to programmedtherapy protocols. When ATP therapy is enabled, control module 80determines whether ATP therapy is delivered or canceled based on inputreceived from electrical sensing module 86 and/or therapy deliverymodule 84 after detecting tachyarrhythmia, e.g., VT or VF.

Therapy delivery module 84 may include a low voltage (LV) therapy module85 for delivering low voltage pacing pulses using anextra-cardiovascular pacing electrode vector selected from electrodes24A, 24B, 28A, 28B, 30 and 15. LV therapy module 85 may be configured todeliver low voltage pacing pulses, e.g., 8 V or less or 10 V or less.One or more capacitors included in the LV therapy module 85 are chargedto a voltage according to a programmed pacing pulse amplitude by a LVcharging circuit, which may include a state machine. The LV chargingcircuit may charge the capacitors to a multiple of the voltage of abattery included in power source 98 without requiring a transformer. Atan appropriate time, the LV therapy module 85 couples the capacitor(s)to a pacing electrode vector to deliver a pacing pulse to the heart 26.

HV therapy module 83 includes one or more high voltage capacitors havinga higher capacitance and a higher voltage rating than the capacitor(s)included in the LV therapy module 85. When a shockable rhythm isdetected, which may be a fast VT or VF, the HV capacitor(s) is(are)charged to a shock voltage amplitude by a HV charging circuit accordingto the programmed shock energy. The HV charging circuit may include atransformer and be a processor-controlled charging circuit that iscontrolled by control module 80. Control module 80 applies a signal totrigger discharge of the HV capacitor(s) upon detecting a feedbacksignal from therapy delivery module 84 that the HV capacitors havereached the shock voltage amplitude required to deliver the programmedshock energy. In this way, control module 80 controls operation of thehigh voltage therapy module 83 to deliver CV/DF shocks usingdefibrillation electrodes 24A, 24B and/or housing 15.

HV therapy module 83 may be used to deliver cardiac pacing pulses,including ATP pulses. In this case, the HV capacitor(s) is(are) chargedto a pacing voltage amplitude that is a much lower voltage than thatused for delivering shock therapies but may be higher than the maximumavailable pulse voltage amplitude produced by the LV therapy module 85.For example, the HV capacitor may be charged to 40 V or less, 30 V orless, or 20 V or less for producing extra-cardiovascular pacing pulses.In some cases the HV capacitor may be charged to 8 to 10 Volts fordelivering ATP, but having a higher capacitance, is capable ofdelivering a longer pulse width than LV therapy module 85.

Compared to pacing pulses delivered by LV therapy module 85, pulseshaving a higher voltage amplitude and/or relatively longer pulse widthmay be produced for delivering higher energy pacing pulses for capturingthe heart. Longer pulse width is attainable due to a higher capacitance(and consequently higher RC time constant) of the HV capacitor(s). TheLV therapy module 85 may be capable of producing a maximum pulse voltageamplitude of up to 8 V or up to and including 10 V. The maximumsingle-pulse pacing pulse width produced by LV therapy module 85 may beup to 2 ms or up to 4 ms in some examples. LV therapy module 85 may beconfigured to produce composite pacing pulses comprising two or moreindividual pulses fused in time to deliver a cumulative composite pacingpulse energy that captures the heart. Techniques for deliveringcomposite pacing pulses are generally disclosed in theabove-incorporated U.S. patent application Ser. No. 15/367,516 (Atty.Docket No. C00012104.USU2) and in U.S. patent application Ser. No.15/368,197 (Atty. Docket No. C00012192.USU2), incorporated herein byreference in its entirety. The maximum composite pacing pulse width maybe up to 8 ms or higher.

The HV therapy module 83 may be capable of producing a pulse voltageamplitude of 10 V or more and may produce mono- or multi-phasic pulseshaving a relatively longer pacing pulse width, e.g., 10 ms or more,because of the higher capacitance of high voltage capacitors included inHV therapy module 83. A typical HV pacing pulse width may be 10 ms;however an example range of available pulse widths may be 2 ms to 20 ms.An example of a maximum voltage amplitude that may be used fordelivering high voltage pacing pulses may be 40 V. When a relativelyhigher pacing pulse voltage amplitude is tolerable by the patient, e.g.,more than 10 V, a relatively shorter pacing pulse width, e.g., 2 to 5ms, may be used during the pacing from HV therapy module 83. However, alonger pacing pulse width may be used as needed, e.g., a 10 V, 20 mspacing pulse.

For the sake of comparison, the HV capacitor(s) of the HV therapy module83 may be charged to an effective voltage greater than 100 V fordelivering a cardioversion/defibrillation shock. For example, two orthree HV capacitors may be provided in series having an effectivecapacitance of 148 to 155 microfarads in HV therapy module 83. Theseseries capacitors may be charged to develop 750 to 800 V for the seriescombination in order to deliver shocks having a pulse energy of 5 Joulesor more, and more typically 20 Joules or more.

In contrast, pacing pulses delivered by the HV therapy module 83 mayhave a pulse energy less than 1 Joule and even in the milliJoule rangeor tenths of milliJoules range depending on the pacing electrodeimpedance. For instance, a pacing pulse generated by HV therapy module83 having a 10 V amplitude and 20 ms pulse width delivered using apacing electrode vector between defibrillation electrodes 24A and 24B,having an impedance in the range of 20 to 200 ohms, may have a deliveredenergy of 5 to 7 milliJoules. When a relatively shorter pulse width isused, e.g., down to 2 ms, the pacing pulse delivered by HV therapymodule 83 using defibrillation electrodes 24A and 24B (or 24A′ and 24B′)may be as low as 1 milliJoule. Pacing pulses delivered by HV therapymodule 83 are expected to have a pacing voltage amplitude that is lessthan 100 V, and typically not more than 40 V, and deliver at least 1milliJoule but less than 1 Joule of energy. The delivered energy for agiven pacing voltage amplitude will vary depending on the pulse widthand pacing electrode vector impedance.

If a pace/sense electrode 28A, 28B or 30 is included in the pacingelectrode vector, resulting in a relatively higher impedance, e.g., inthe 400 to 1000 ohm range, the pacing pulse energy delivered may be inthe range of 2 to 5 milliJoules. In contrast, pacing pulses delivered bya LV therapy module included in a transvenous ICD system orintra-cardiac pacemaker, e.g., as shown in FIGS. 10 and 11,respectively, using endocardial electrodes may be on the order ofmicroJoules, e.g., 2 microJoules to 5 microJoules for a typicalendocardial pacing pulse that is 2V in amplitude, 0.5 ms in pulse widthand applied across a pacing electrode vector impedance of 400 to 1000ohms.

HV therapy module 83 may deliver more current via a lower impedancepacing electrode vector, e.g., between defibrillation electrodes 24A and24B or 24A′ and 24B′, than the current delivered by LV therapy module 85via a pacing electrode vector including a pace/sense electrode 28A, 28Bor 30 (relatively higher impedance) even when the pacing voltageamplitude is the same.

In some instances, control module 80 may control impedance measurementmodule 90 to determine the impedance of a pacing electrode vector.Impedance measurement module 90 may be electrically coupled to theavailable electrodes 24A, 24B, 28A, 28B, 30 and housing 15 forperforming impedance measurements of one or more candidate pacingelectrode vectors. Control module 80 may control impedance measurementmodule 90 to perform impedance measurements by passing a signal toimpedance measurement module 90 to initiate an impedance measurement ofa pacing electrode vector. Impedance measurement module 90 is configuredto apply a drive or excitation current across a pacing electrode vectorand determine the resulting voltage. The voltage signal may be useddirectly as the impedance measurement or impedance may be determinedfrom the applied current and the measured voltage. The impedancemeasurement may be passed to control module 80.

As described in conjunction with FIG. 6, control module 80 may use theimpedance measurement to set a variable shunt resistance included in HVtherapy module 83 when HV therapy module 83 is delivering pacing pulsesto heart 26. The variable shunt resistance may be parallel to the pacingload and set to maintain electrical current through HV therapy moduleswitching circuitry throughout the duration of a pacing pulse deliveredby the HV therapy module 83 thereby promoting an appropriate voltagesignal across the pacing load for capturing the patient's heart.

Control parameters utilized by control module 80 for detecting cardiacrhythms and delivering electrical stimulation therapies andtachyarrhythmia induction pulses may be programmed into memory 82 viatelemetry module 88. Telemetry module 88 includes a transceiver andantenna for communicating with external device 40 (shown in FIG. 1A)using RF communication as described above. Under the control of controlmodule 80, telemetry module 88 may receive downlink telemetry from andsend uplink telemetry to external device 40. In some cases, telemetrymodule 88 may be used to transmit and receive communication signalsto/from another medical device implanted in patient 12.

FIG. 6 is schematic diagram 200 of HV therapy module 83 coupled to aprocessor and HV therapy control module 230. HV therapy module 83includes a HV charging circuit 240 and a HV charge storage and outputmodule 202. Processor and HV therapy control module 230 may be includedin control module 80 for controlling HV charging circuit 240 and HVcharge storage and output module 202. HV charge storage and outputmodule 202 includes a HV capacitor 210 coupled to switching circuitry204 via a pulse control switch 206 for coupling the HV capacitor 210 toelectrodes 24 a, 24 b and/or housing 15 to deliver a desired electricalstimulation pulse to the patient's heart 26. HV capacitor 210 is shownas a single capacitor, but it is recognized that a bank of two or morecapacitors or other energy storage devices may be used to store energyfor producing electrical signals delivered to heart 26. In one example,HV capacitor 210 is a series of three capacitors having an effectivecapacitance of 148 to 155 microfarads with a high voltage rating toenable charging up to an effective charge of 800 V or more. In contrast,holding capacitors that are included in LV therapy module 85 that arecharged to a multiple of the battery voltage by a state machine orcapacitor charge pump circuit may have a capacitance of up to 6microfarads, up to 10 microfarads, up to 20 microfarads or otherselected capacitance, but all have a capacitance significantly less thanthe effective capacitance of high voltage capacitor 210. The LV therapymodule 85 has a lower breakdown voltage than the HV therapy module 83,allowing the HV capacitor 210 to be charged to the shock voltageamplitude required for delivering CV/DF shocks.

HV charging circuit 240 receives power from power source 98 (FIG. 5) forcharging capacitor 210 as needed. HV charging circuit 240 includes atransformer 242 to step up the battery voltage of power source 98 inorder to achieve charging of capacitor 210 to a voltage that is muchgreater than the battery voltage. Charging of capacitor 210 by HVcharging circuit 240 is performed under the control of processor and HVtherapy control 230, which receives feedback signals from HV chargestorage and output module 202 to determine when capacitor 210 is chargedto a programmed voltage. A charge completion signal is passed to HVcharging circuit 240 to terminate charging by processor and HV therapycontrol module 230. One example of a high voltage charging circuit andits operation is generally disclosed in U.S. Pat. No. 8,195,291 (Norton,et al.), incorporated herein by reference in its entirety.

When control module 80 determines that delivery of an electricalstimulation pulse from HV therapy module 83 is needed, switchingcircuitry 204 is controlled by signals from processor and HV therapycontrol module 230 to electrically couple HV capacitor 210 to a therapydelivery vector to discharge capacitor 210 across the vector selectedfrom electrodes 24 a, 24 b and/or housing 15. Switching circuitry 204may be in the form of an H-bridge including switches 212 a-212 c and 214a-214 c that are controlled by signals from processor and HV controlmodule 230. Switches 212 a-212 c and 214 a-214 c may be implemented assilicon-controlled rectifiers (SCRs), insulated-gate bipolar transistors(IGBTs), metal-oxide-semiconductor field-effect transistors (MOSFETs),and/or other switching circuit components. The selected electrodes 24 a,24 b and/or housing 15 are coupled to HV capacitor 210 by opening (i.e.,turning off or disabling) and closing (i.e., turning on or enabling) theappropriate switches of switching circuitry 204 to pass a desiredelectrical signal to the therapy delivery electrode vector, which may bea shock electrode vector or a pacing electrode vector that is the sameor different that the shock electrode vector. While only electrodes 24A,24B and housing 14 are indicated in as being coupled to switchingcircuitry 204, it is to be understood that pace/sense electrodes 28A,28B and 30 may be coupled to switching circuitry 204 and available foruse in a pacing electrode vector.

When control module 80 determines that a shock therapy is needed basedon a detected heart rhythm, e.g., VT or VF, the electrical signaldelivered by HV therapy module 83 may be a monophasic, biphasic or othershaped CV/DF shock pulse for terminating the ventriculartachyarrhythmia. When control module 80 determines that a pacing therapyis needed based on a VT or VF detection, HV therapy module 83 maydeliver a series of monophasic or biphasic pacing pulses according to aprogrammed ATP protocol. Methods for confirming ATP delivery criteriaand controlling the timing of ATP therapy delivery are described below,e.g., in conjunction with the accompanying flow charts of FIGS. 7 and 8and 12.

In some examples, when a biphasic CV/DF shock or biphasic pacing pulseis needed, one of switches 212 a, 212 b and 212 c may be closedsimultaneously with one of switches 214 a, 214 b and 214 c withoutclosing both of the “a,” “b” or “c” switches across a given electrode 24a, 24 b or housing 15, respectively, at the same time. To deliver abiphasic pulse using electrode 24 a and housing 15, for instance, switch212 a and 214 c may be closed to deliver a first phase of the biphasicpulse. Switches 212 a and 214 c are opened after the first phase, andswitches 212 c and 214 a are closed to deliver the second phase of thebiphasic pulse. Switches 212 b and 214 b remain open or disabled in thisexample with electrode 24 b not selected or used in the therapy deliveryvector. In other examples, electrode 24B may be included instead ofelectrode 24A or simultaneously activated with electrode 24A by closingswitch 212 b during the first phase and closing switch 214 b in thesecond phase of the illustrative biphasic pulse. The first phase of abiphasic pulse may be terminated when the pulse voltage amplitude hasdecayed according to a programmed “tilt” or percentage of the leadingvoltage amplitude of the pacing pulses. For example, the first phase maybe terminated when the pulse voltage amplitude has decayed to 50% of theleading voltage amplitude.

In response to detecting a tachyarrhythmia for which ATP pacing therapyis enabled, control module 80 prepares HV therapy module 83 to deliverATP by adjusting the electrical charge of capacitor 210 to a programmedpacing voltage amplitude under the control of processor and HV therapycontrol module 230. In some instances, HV capacitor 210 may be chargedup to the pacing voltage amplitude by HV charging circuit 240. At othertimes, HV capacitor 210 may retain a residual charge after being chargedfor a previous therapy, e.g., a previous pacing therapy or CV/DF shockdelivery, or for capacitor maintenance. In this case, HV capacitor 210may be adjusted to the pacing voltage amplitude by electrically couplingHV capacitor 210 to a non-therapeutic load 205 shown schematically inFIG. 6, for dumping energy to reduce the charge of HV capacitor 210 fromthe residual charge to the pacing voltage amplitude. The non-therapeuticload 205 may be a resistor or bank of resistors in therapy deliverymodule 84 and in some examples may utilize shunt resistors 250 and 252.A charge dumping switch 207 may be closed by processor and HV therapycontrol 230 to discharge HV capacitors 210 through the non-therapeuticload 205.

After confirming that the HV capacitor 210 has reached the pacingvoltage amplitude, and after any ATP delivery criteria confirmationrequired for ATP therapy delivery as described in conjunction with thetechniques described below, including FIG. 7, ATP pulses are delivered.Switches 212 a-212 c and 214 a-214 c are controlled to be open or closedby processor and HV therapy control module 230 at the appropriate timesfor delivering a monophasic, biphasic or other desired ATP pulse bydischarging capacitor 210 across the pacing load presented by heart 26and a selected pacing electrode vector. The capacitor 210 is coupledacross the selected pacing electrode vector for the programmed pacingpulse width by controlling pulse control switch 206.

HV charge storage and output module 202 is shown to include an optionalshunt resistance 250 in parallel to the pacing load shown schematicallyas heart 26 when electrodes 24A and 24B are selected as the anode andcathode (or cathode and anode, respectively) of the pacing electrodevector. It is recognized that a shunt resistance may be provided inparallel to the pacing load for any selected pacing electrode vector,for example shunt resistance 252 is shown schematically if the pacingelectrode vector includes electrode 24B and housing 15. Likewise a shuntresistance may be provided in parallel to the pacing load when thepacing electrode vector includes electrode 24A and housing 15.

Switches 212 a-212 c and switches 214 a-214 c may require a minimumcurrent flow to hold them closed (i.e., ON or enabled) for passingcurrent as capacitor 210 is discharged. This minimum current may be onthe order of approximately 10 milliamps. Depending on the pacing loadimpedance and other conditions, the electrical current passing throughenabled switches of switches 212 a-212 c and 214 a-214 c may fall belowthe minimum current required to keep the switches closed as capacitor210 is discharged across a selected pacing vector. If the currentpassing through a respective switch falls below the minimum currentrequired to keep the switch closed, the switch may open (or becomedisabled) causing premature truncation of the pacing pulse, which couldresult in loss of capture. As such, a minimum pacing pulse voltageamplitude may be set for delivering pacing pulses from HV therapy module83 in order to reduce the likelihood of the electrical current producedduring capacitor 210 discharge falling below the minimum currentrequired to maintain a stable state of enabled switches of switchingcircuitry 204 during a programmed pacing pulse width.

The shunt resistance 250 or 252 may be a variable resistance that is setto match a pacing electrode vector impedance so that the load acrossheart 26 using a selected pacing electrode vector matches the shuntresistance. In this way, current through the switching circuitry 204 maybe maintained at or above a minimum current required to maintain astable state of enabled switches of switching circuitry 204 during thepacing pulse. The shunt resistance 250 may be set to a resistance thatmaintains the electrical current to selected switches of switchingcircuitry 204 at or above the minimum current required to hold theselected switches in the closed or enabled state.

If the shunt resistance 250 or 252 is lower than the pacing electrodevector impedance, current produced by discharging capacitor 210 may beshunted away from the pacing load, e.g., the pacing electrode vectorbetween electrodes 24 a and 24 b and heart 26, potentially resulting inless energy delivered to heart 26, which may result in loss of capture.Accordingly, processor and HV therapy control module 230 may beconfigured to retrieve a pacing electrode vector impedance measurementfrom impedance measurement module 90 and set the shunt resistance 250(or 252) to match the pacing electrode vector impedance.

In other examples, a minimum voltage charge of capacitor 210 may be setto provide the minimum current required to maintain an enabled state ofselected switches of switching circuitry 204, but pacing energy may beintentionally shunted away from the pacing load including heart 26 inorder to reduce the delivered pacing pulse energy. If the pacingamplitude capture threshold is below the minimum voltage amplituderequired to maintain the minimum current to keep switches 212 a-212 cand 214 a-214 c on when they are enabled by processor and HV therapycontrol module 230, the energy delivered across the pacing electrodevector may be reduced by setting the variable shunt resistance 250 (or252) to a value that is less than the pacing electrode vector impedance.This current shunting may reduce skeletal muscle recruitment caused bythe extra-cardiovascular pacing pulse while still providing effectivecapture of heart 26.

Since the range of pacing load impedances and pacing voltage amplitudesmay vary between patients and over time within a patient, a variableshunt resistance may be provided to enable selection of the appropriateresistance for shunting the required current through the switchingcircuitry 204. It is contemplated, however, that in some examples afixed resistance shunt may be provided. For example, the resistanceneeded to shunt current to the switching circuitry 204 when the pacingload impedance is high may still shunt some current to the switchingcircuitry when the pacing load impedance is relatively lower. An optimalvalue for a fixed resistance shunt may be determined based on empiricaldata, e.g., typical pacing load impedances and pacing pulse voltageamplitudes used clinically.

The pacing electrode vector coupled to HV capacitor 210 via switchingcircuitry 204 may include electrodes 24 a, 24 b, 28 a, 28 b and/or 30carried by lead 16. Housing 15 may be unused for cardiac pacing pulsedelivery by holding switches 212 c and 214 c open. Depending on theimplant location of ICD 14 and lead 16 and the resulting electricalstimulation delivery vector between the housing 15 and an electrode 24a, 24 b, 28 a, 28 b or 30, greater recruitment of skeletal muscle mayoccur when housing 15 is included in the pacing electrode vector. Alarger volume of skeletal muscle tissue may lie along a vector extendingbetween the distal portion 25 of lead 16 and housing 15 than along avector extending between the two electrodes carried by lead distalportion 25. In the example configurations of FIGS. 1A-2C, for example, apacing pulse may be delivered between electrodes 24 a and 24 b, betweenelectrodes 28A and 28B, between electrodes 28A and 24A or betweenelectrodes 28B and 24B to limit skeletal muscle recruitment compared toa pacing electrode vector that includes housing 15. In other electrodeconfigurations and implant locations, the electrodes used to deliverextra-cardiovascular pacing pulses by HV therapy module 83 may includehousing 15 and may be selected to provide a pacing electrode vector thatminimizes the volume of skeletal muscle recruited during pacing pulsedelivery while still directing sufficient energy to the heart 26 forcapturing and pacing the heart.

FIG. 7 is a flow chart 100 of a method for controlling ATP therapydelivery by HV therapy module 83 according to one example. At block 102,control module 80 monitors the cardiac electrical signal(s) receivedfrom sensing circuit 86 for detecting tachyarrhythmia. As describedabove, control module 80 may at least determine RRIs between consecutiveR-wave sensed event signals received from sensing circuit 86 fordetecting ventricular tachyarrhythmias. Control module 80 may includetachyarrhythmia interval counters for counting RRIs as they aredetermined that fall into a VT interval zone and/or a VF interval zone.If VT detection is enabled and a VT internal counter reaches a thresholdnumber of intervals to detect (NID) set for detecting VT, VT may bedetected at block 104. If a VF interval counter reaches an NID set fordetecting VF, VF may be detected at block 104. In other examples,control module 80 may be configured to perform additional signalanalyses of sensed waveforms and/or longer segments of the cardiacelectrical signal(s), such as morphological analysis for confirmingR-waves or discriminating supraventricular tachyarrhythmia, analysis forelectrical noise detection, T-wave oversensing detection, and/or othersignal analysis. Additional signal analysis may be performed on one ormore sensing electrode vector signals in various combinations. Examplesof tachyarrhythmia detection methods are generally disclosed in U.S.Pat. No. 6,393,316 (Gillberg et al.); U.S. Pat. No. 7,031,771 (Brown, etal.); U.S. Pat. No. 8,160,684 (Ghanem, et al.), U.S. Pat. No. 8,437,842(Zhang, et al.) and provisional U.S. Pat. Application No. 62/367,166(filed Jul. 27, 2016), all of which are incorporated herein by referencein their entirety.

If tachyarrhythmia is detected at block 104, the control module 80determines if ATP therapy is enabled at block 105 according to aprogrammed therapy protocol. If the programmed therapy protocol includesATP delivery prior to attempting a CV/DF shock, as determined at block105, control module 80 may advance to block 110 to prepare the HVcapacitor of HV therapy module 83 for ATP delivery. If ATP is notenabled for delivery following tachyarrhythmia detection, control module80 may control HV therapy module 83 to charge the HV capacitor 210 to ashock voltage amplitude according to a programmed shock energy anddeliver a CV/DF shock at block 109. Control module 80 returns to block102 after therapy delivery to monitor the cardiac signal for redetectingthe tachyarrhythmia episode if not successfully terminated or, ifterminated, detecting a new episode in the future.

If ATP is enabled at block 105, control module 80 delays the ATP therapyat block 106 for a period of time during which control module 80 maydetermine if ATP delivery criteria are met and/or may prepare the HVcapacitor 210 for ATP delivery. Control module 80 may optionallydetermine whether charge adjustment criteria are met at block 107 basedon the charge of HV capacitor 210. For example, if the charge of HVcapacitor 210 is greater than a charge adjustment threshold at block107, charge adjustment criteria may be determined to be unmet.

In some instances, HV capacitor 210 may retain a residual charge from apreceding therapy or capacitor maintenance charging that is greater thanthe programmed pacing voltage amplitude to be used for delivering ATP.In some cases, residual charge may be dumped after a high voltagetherapy or capacitor maintenance charging to enable the HV capacitor 210to be ready for charging to the pacing voltage amplitude. However, aresidual charge may remain on the HV capacitor 210 at the time that thetachyarrhythmia is detected and ATP is needed. The process of adjustingthe HV capacitor charge from a relatively high voltage to the pacingvoltage amplitude for ATP by charge dumping through a non-therapeuticload may result in an unacceptable delay time between tachyarrhythmiadetection and therapy delivery. In some examples, therefore, if the HVcapacitor charge is greater than a charge adjustment threshold, controlcircuit 80 may cancel the ATP therapy at block 108 and advance to block109 to deliver the next therapy in a menu of therapies programmed fortreating the detected tachyarrhythmia, e.g., a shock therapy.

The charge adjustment threshold used to determine if charge adjustmentcriteria are met for timely delivery of ATP from the HV therapy module83 may be a predetermined voltage that is greater than the pacingvoltage amplitude and less than the shock voltage amplitudecorresponding to a programmed shock energy. For example, the HVcapacitor charge may be compared to the pacing voltage amplitude plus apredetermined charge difference. The predetermined charge difference maybe on the order of 20 to 40 Volts in some examples. In other examples,the charge adjustment threshold may be a predetermined percentage of theshock voltage amplitude or a predetermined percentage of the pacingvoltage amplitude, for example twice the pacing voltage amplitude.

In still other examples, the difference between the HV capacitor chargeat the time of tachyarrhythmia detection and the programmed pacingvoltage amplitude may be determined at block 107, and this differencemay be compared to a charge adjustment threshold. If the difference isnot greater than the charge adjustment threshold, control module 80 mayadvance to block 110 to prepare the HV capacitor 210 for ATP delivery.The charge adjustment threshold may be defined based on the timeduration necessary to dump the voltage difference through anon-therapeutic load. If the difference is greater than the chargeadjustment threshold, the time required to dump excess charge mayunacceptably delay therapy for terminating the detected tachyarrhythmia.In that case, control module 80 may advance to block 108 and cancel theATP therapy.

To illustrate, if the HV capacitor 210 is charged to 520 V and theprogrammed ATP pacing voltage amplitude is 20 V, the charge differenceis 500 V. The time to dump the excess 500 V charge may be approximatelyfifteen seconds, depending on the RC time constant of thenon-therapeutic load, which may be an unacceptably long delay in therapydelivery. In this case, control module 80 would make the decision tocancel ATP and deliver a shock therapy at blocks 108 and 109,respectively. However, if the HV capacitor charge is 50 V at the time ofdetecting the tachyarrhythmia and the ATP pacing voltage amplitude is 20V, the time required to dump the excess 30 V through a non-therapeuticload may be approximately two seconds. In this case, control module 80may advance to block 110 to begin preparing the HV capacitor 210 for ATPdelivery. The charge adjustment threshold may be set based on a chargedifference that can be dumped through the non-therapeutic load 205within a predetermined acceptable ATP delay time. Acceptable ATP delaytime may be 10 seconds, 8 seconds, 5 seconds, 3 seconds, 2 seconds, oranother predetermined time interval.

In another example, control module 80 may determine an estimated time todump the excess charge based on the charge difference between the HVcapacitor charge and the ATP pacing voltage amplitude and a known RCtime constant of HV capacitor 210 and the non-therapeutic load.Estimated charge dumping time may be computed or fetched from a look-uptable stored in memory 82 for a range of different charge differencevalues. The charge adjustment criteria may be determined to be met atblock 107 when the estimated charge dumping time is less than or equalto a predetermined acceptable therapy delay time.

In some examples, the ATP pulses may be delivered at a pulse voltageamplitude that is at or within a tolerance range of the programmedpacing voltage amplitude for ATP. For example, a voltage tolerance maybe set to a fixed voltage interval or a percentage of the programmed ATPpacing voltage amplitude. Determination of whether the charge adjustmentcriteria are met at block 107 may be based on the programmed pacingvoltage amplitude plus the tolerance. For instance, the tolerance may beset to a fixed value, e.g., 5 Volts, or a percentage of the programmedpacing voltage amplitude, e.g., 20%. In some examples, the tolerance maybe zero. If the charge difference between the HV capacitor charge at thetime of the tachyarrhythmia detection and the pacing voltage amplitudeplus the tolerance is less than a charge adjustment threshold, or thetime to dump charge down to the pacing voltage amplitude plus thetolerance is less than or equal to an acceptable therapy delay time, thecharge adjustment criteria may be determined to be met at block 107.

At block 110, control module 80 controls HV therapy module 83 to preparethe HV capacitor 210 for delivery of ATP by adjusting the charge of theHV capacitor 210 to the programmed pacing voltage amplitude or within apredetermined tolerance thereof. The HV capacitor 210 may need to becharged to the programmed pacing voltage amplitude for delivering ATPpulses when the HV capacitor charge at the time of the tachyarrhythmiadetection is less than the pacing voltage amplitude. At other times aresidual charge may remain after a previous CV/DF shock or otherprevious therapy or after capacitor maintenance charging. If theresidual charge of the HV capacitor 210 is greater than the programmedpacing voltage amplitude for ATP delivery, but charge adjustmentcriteria are met at block 107, the HV therapy module 83 is adjusted tothe pacing voltage amplitude by controlling the HV charge storage andoutput module 202 to dump energy at block 110 by discharging the HVcapacitor 210 through a non-therapeutic load 205 (FIG. 6).

The processor and HV therapy control module 230 may monitor the voltageof HV capacitor 210 and terminate the energy dumping when the capacitorvoltage reaches the pacing voltage amplitude. In some instances, thecapacitor voltage may fall below the pacing voltage amplitude duringenergy dumping and the HV charging circuit 240 may be controlled torecharge the HV capacitor 210 to the pacing voltage amplitude. In otherinstances, control module 230 may determine that the HV capacitor isprepared and ready for ATP therapy delivery once the HV capacitor chargereaches the programmed pacing voltage amplitude plus a tolerance. If thetime required for charge dumping to the programmed pacing voltageamplitude exceeds an acceptable ATP therapy delay time, the chargedumping may be terminated when the HV capacitor charge reaches thepacing voltage amplitude plus a tolerance, e.g., 5 V or other fixedvalue or a predetermined percentage of the pacing voltage amplitude,e.g., 20%.

While control module 80 waits for an ATP therapy delay period while theHV capacitor preparation is occurring at block 110, control module 80may determine one or more RRIs at block 112, after the VT or VFdetection has been made. In response to a signal from processor and HVtherapy control module 230 indicating that the HV capacitor charge is atthe pacing voltage amplitude (or within a voltage tolerance of thepacing voltage amplitude) and ready for ATP delivery (block 114),control module 80 determines if ATP delivery criteria are met at block116. One or more of the RRIs determined during HV capacitor preparationmay be compared to a synchronization interval at block 116. At least theearliest RRI immediately following confirmation of the HV capacitorcharge being at the pacing voltage amplitude or the most recent RRIimmediately preceding confirmation of the HV capacitor charge being atthe pacing voltage amplitude is compared to the synchronizationinterval. If a threshold number of RRIs are greater than thesynchronization interval, the ATP delivery criteria may be unmet atblock 116.

The synchronization interval may be established by control module 80 atblock 116 based on the rate of the detected tachyarrhythmia. Forexample, a mean or median RRI may be determined from a predeterminednumber of RRIs immediately prior to VT or VF detection (or redetection).In one example, six most recent RRIs prior to detection are used fordetermining the synchronization interval. The minimum and the maximum ofthe six RRIs may be dropped and the mean RRI of the remaining four RRIsis determined. A fixed interval, e.g., 60 ms, may be added to the meanto determine the synchronization interval.

In other examples, the synchronization interval may be established bycontrol module 80 at block 116 based on the longest programmedtachyarrhythmia detection interval. When VT detection is enabled, thesynchronization interval may be the VT detection interval or the VTdetection interval plus a fixed interval. For example, if the maximum VTdetection interval is 360 ms, the synchronization interval may be the VTdetection interval plus a fixed interval, e.g., 0 to 60 ms. If VTdetection is not enabled, the synchronization interval may be thelongest VF detection interval, e.g., 320 ms plus a fixed interval, e.g.,0 to 60 ms.

In some examples, the synchronization interval is determined at block116 based on the detected rate, e.g., using the most recent six (orother predetermined number of RRIs), unless the last RRIs prior todetection have a range greater than a range threshold. For example, ifthe largest and smallest RRIs out of the last six RRIs prior todetection are within 50 ms of each other, the synchronization intervalis determined based on the mean of the remaining four RRIs, referred toas the “trimmed mean.” If the largest and smallest RRIs out of the sixRRIs are more than 50 ms apart, the synchronization interval isdetermined based on the longest detection interval for the rhythm beingdetected plus a fixed interval. In still other examples, thesynchronization interval may be determined by control module 80 as beingthe largest one out of the maximum detection interval and trimmed mean.For instance if the tachyarrhythmia is detected based on RRIs in the VFinterval zone, the synchronization interval may be set as the maximumfibrillation detection interval or the trimmed mean, whichever isgreater, plus 60 ms.

If a threshold number of RRIs determined during the HV capacitorpreparation are less than the synchronization interval at block 116, theATP delivery criteria are met. In one example, if at least X out of YRRIs determined after tachyarrhythmia detection and during (and/orafter) the HV capacitor preparation are less than or equal to thesynchronization interval, the ATP delivery criteria are met. The valuesof X and Y may be programmable where X may be one or more and Y is anyvalue equal to or greater than X. For example, 3 out of 4 RRIs may berequired to be less than the synchronization interval though otherratios or percentages may be used.

In some cases Y RRIs may not be reached during the HV capacitorpreparation. If fewer than Y RRIs have occurred when the HV capacitor isready for ATP delivery at block 114, control module 80 may determine themost recent RRI and compare it to the synchronization interval. If themost recent RRI is less than the synchronization interval, the ATPdelivery criteria are met at block 116. In other examples, the ATPdelivery criteria requires that two or more most recent RRIs, eitherimmediately preceding and/or immediately following the completion of HVcapacitor preparation, be less than the synchronization interval.

In other examples, the ATP delivery criteria may require that at leastthe most recent RRI is greater than a minimum ATP pacing interval orminimum synchronization interval for delivering ATP. If the most recentRRI, or a threshold number of the determined RRIs are shorter than theminimum synchronization interval, the ATP delivery criteria may be unmetat block 116. In some instances, for example if asystole occurs, controlmodule 80 may be unable to determine an adequate number of RRIs fordetermining if ATP delivery criteria are satisfied. In this case, theATP delivery criteria may be determined to be unmet at block 116.

In response to the ATP delivery criteria being met, ATP is delivered atblock 118. The HV therapy module 83 is controlled to deliver the firstATP pulse synchronized to the latest sensed R-wave that occurred at anRRI confirmed to be less than (or equal to) the synchronizationinterval. The first ATP pulse is synchronized to a sensed R-wave bysetting the first ATP pacing interval to an interval less than thedetected rate of the tachyarrhythmia (and less than the synchronizationinterval) and delivering the first ATP pulse upon expiration of thepacing interval. The first and subsequent ATP pulses are delivered bydischarging the HV capacitor 210 via the switching circuitry 204according to a programmed ATP protocol, e.g., a burst of 6 to 10 pulsesdelivered at a rate that is faster than the detected tachyarrhythmiarate and according to a programmed pacing voltage amplitude and pacingpulse width.

At least the first, leading pulse of the ATP pulses is delivered havingthe pacing voltage amplitude. The HV capacitor 210 may be recharged tothe pacing voltage amplitude prior to each ATP pulse, after deliveringthe preceding ATP pulse, to deliver all the ATP pulses having the pacingvoltage amplitude. In other examples, the first pulse may be deliveredat the pacing voltage amplitude and subsequent pulses may be deliveredat a different voltage amplitude. Subsequent pulses may be delivered ata lower voltage amplitude, for example, and may have the same or alonger pulse width than the leading ATP pulse. The leading ATP pulse maybe delivered with a relatively higher pacing voltage amplitude to ensurecapture and paced control of the heart rhythm. After ATP delivery,control module 80 returns to block 102 to continue monitoring thecardiac signal for detecting or redetecting tachyarrhythmia.

If the ATP delivery criteria are not met at block 116, the delayed ATPtherapy is withheld at block 120. The control module 80 may return toblock 102 to continue monitoring the cardiac signal. The detectedtachyarrhythmia may have slowed or spontaneously terminated such thatATP is no longer required. The HV capacitor 210 may be held at thepacing voltage amplitude reached during HV capacitor preparationperformed at block 110 when ATP therapy is withheld such that if thetachyarrhythmia is redetected or a subsequent tachyarrhythmia isdetected before other therapy is needed, the HV therapy module 83 isready to deliver ATP if the ATP delivery criteria do become satisfied.

In other cases, after canceling ATP at block 120, a fast VT or VF may bedetected as a shockable rhythm at block 105 that requires shock therapy.In this case, control module 80 may advance to block 109 withoutdelivering ATP and may charge the HV capacitor 210 from the pacingvoltage amplitude held after canceling ATP to a shock voltage amplitudecorresponding to a programmed shock energy. A CV/DF shock pulse is thendelivered at block 109.

FIG. 8 is a flow chart 150 of a method for controlling ATP delivery byICD 14 according to another example. Operations performed at blocks102-110, 116, 118, and 120 in flow chart 150 may generally correspond toidentically-numbered blocks shown in FIG. 7 and described above. In FIG.8, RRIs are determined at block 212 by control module 80 to determine ifthe rate of the detected tachyarrhythmia has changed or is steady sincethe detection was made at block 104. Control module 80 may determine ifthe rate is steady, slowing, or accelerating at block 212. Thisdetermination may be made by determining the synchronization interval(as described above) and comparing RRIs determined during the HVcapacitor preparation to the synchronization interval and/or otherthreshold intervals based on the synchronization interval. The heartrate may be determined to be steady if a predetermined percentage of theRRIs determined during the HV capacitor adjustment are within aninterval range corresponding to the detected tachyarrhythmia rate orwithin an interval range based on the synchronization interval. Theinterval range may extend from an accelerating threshold interval to aslowing threshold interval.

If a predetermined percentage of the determined RRIs, or X out Ydetermined RRIs, are longer than a slowing threshold interval thetachyarrhythmia rate may be determined to be slowing at block 212. Aslowing threshold interval may be determined by control module 80 as thesynchronization interval plus a time interval, e.g., the synchronizationinterval plus 30 to 80 ms. It is contemplated that other methods may beused to detect a slowing rate of the detected tachyarrhythmia, e.g., bycomparing consecutive RRIs to each other, to a running average or othertechniques for detecting an increasing trend of the RRIs aftertachyarrhythmia detection compared to before tachyarrhythmia detection.

If a predetermined percentage of RRIs or X out Y RRIs are shorter thanan accelerating threshold interval, the tachyarrhythmia rate may bedetermined to be an accelerating rate. The accelerating thresholdinterval may be set as the synchronization interval less a timeinterval, e.g., 30 to 80 ms less than the synchronization interval. Inthis illustrative example, the tachyarrhythmia rate is determined asbeing steady if the predetermined percentage or X out of Y RRIs fallwithin the range between the slowing threshold interval and theaccelerating threshold interval, which may be referred to as a steadyrate interval range.

If the rate is determined to be steady at block 212, control module 80may determine if the HV capacitor is ready at block 218. If the HVcapacitor is not yet at the pacing voltage amplitude, control module 80may return to block 110 to continue adjusting the HV capacitor chargeand continue comparing RRIs to the rate criteria at block 212.

If the rate is steady and the HV capacitor is ready, “yes” branch ofblock 218, control module 80 may proceed to verifying whether the ATPdelivery criteria are met at block 116 as described above in conjunctionwith FIG. 7. In some examples, the ATP delivery criteria may bedetermined as being met based on determining a steady rate. The ATPtherapy may be delivered at block 118, with the first ATP pulsesynchronized to the earliest sensed R-wave occurring at an RRI less thanor equal to the synchronization interval after the HV capacitor isready.

If the rate is non-steady (“no” branch of block 212), e.g., if the rateis slowing or accelerating based on sensed event intervals not remainingwithin an interval range, HV capacitor preparation may be terminated atblock 220 in some examples. For example, if charge is being dumped foradjusting the HV capacitor 210 to the pacing voltage amplitude, thecharge dumping may be terminated. If the HV capacitor 210 is beingcharged to the pacing voltage amplitude, the charging may be terminated.If the rate is slowing, the arrhythmia may be spontaneously terminating,and no therapy may be needed.

If the rate is accelerating, however, a therapy may still be required.In the case of an accelerating rate, capacitor charging to at least thepacing voltage amplitude may be completed at block 220 even though ATPis canceled at block 120. The HV capacitor charge may be held at thepacing voltage amplitude in anticipation of a needed therapy. If chargedumping is being performed at the time of determining that the rate isaccelerating, charge dumping may be terminated at block 220 and theresidual charge of the HV capacitor 210 may be held in anticipation of aneeded therapy.

In either case of terminating or completing charge adjustment at block220, the ATP may be canceled at block 120 since the therapy may nolonger be required (if the rate is slowing) or a different therapy maybe needed (if the rate is accelerating). Control module 80 returns toblock 102 to analyze the cardiac signal for redetecting thetachyarrhythmia, which may have terminated, remained in the original VTor VF detection zone, or accelerated within the VT zone or from the VTzone to the VF zone. By redetecting the tachyarrhythmia, the mostappropriate therapy for the accelerating rhythm may be delivered, anddelivery of a potentially sub-optimal or unnecessary therapy is avoided.

FIG. 9 is a flow chart 300 of a method for adjusting detectionparameters in response to canceling an ATP therapy. The process of flowchart 300 provides additional steps that may be performed in response todetermining a non-steady rate at block 212 of FIG. 8, shown again inFIG. 9. In response to determining that the rate is not steady, “no”branch of block 212, control module 80 may determine if ATP has beencanceled a threshold number of times at block 304 due to a non-steadyrate. In some examples, the determination at block 212 includesdetermining whether or not the rate is slowing or accelerating asdescribed above.

If the rate is not steady and is slowing at block 212, the ATP iscanceled as described in conjunction with FIG. 8. If ATP has not beenwithheld or canceled a threshold number of times (block 304), noadjustments to the tachyarrhythmia detection criteria are made at block308. Control module 80 returns to monitoring the cardiac electricalsignal after canceling ATP therapy, as described in conjunction withFIG. 8, to determine if the tachyarrhythmia is spontaneously terminatingor if VT is still being detected using the same tachyarrhythmiadetection criteria.

If ATP has been withheld or canceled a threshold number of times due toa slowing rate as determined at block 304, control module 80 may adjustthe tachyarrhythmia detection criteria at block 306. For example, ifmonomorphic VT has been detected and ATP withheld due to a slowing rateof the monomorphic VT during HV capacitor preparation, the VT detectioncriteria may be adjusted to increase the time it takes for controlmodule 80 to detect VT, e.g., by increasing the NID. For instance, ifATP has been withheld three times due to a slowing rate of a monomorphicVT, the NID used to detect VT may be increased at block 306.

In other examples, if the rate is determined to be non-steady andaccelerating at block 212, ATP is withheld as described above, andcontrol module 80 may advance to block 304 to determine if ATP has beenwithheld a threshold number of times in response to detecting anaccelerating rate during HV capacitor preparation. If ATP has beenwithheld a threshold number of times due to an accelerating rate,detection criteria may be adjusted at block 306 to enable earlierdetection of a shockable VT or VF rhythm, e.g., by adjusting the fast VTor VF detection interval and/or reducing the number of intervalsrequired to detect a fast VT or VF as a shockable rhythm.

It is contemplated that tachyarrhythmia detection criteria may beadjusted at block 306 after ATP has been canceled a threshold number oftimes only due to rate slowing during HV capacitor preparation, only dueto rate acceleration during HV capacitor preparation, or for both casesof rate slowing and for rate acceleration. It is understood that thedetection criteria are adjusted differently for the two cases of aslowing rate and an accelerating rate. The threshold number of times forcanceling ATP prior to adjusting detection criteria may be one or moretimes and may be different for rate slowing than for rate acceleration.

In the examples described above, ATP is delivered by HV therapy module83 of extra-cardiovascular ICD 14. In other examples, some aspects ofthe techniques disclosed herein may be used to control ATP therapydelivery by LV therapy module 85 of ICD 14 or by a similar LV therapymodule of an ICD or pacemaker coupled to one or more transvenous leadscarrying endocardial electrodes, an ICD or pacemaker coupled to one ormore leads carrying epicardial electrodes, or an intra-cardiac pacemakerconfigured to deliver ATP. The determination whether ATP deliverycriteria are met after detecting ventricular tachyarrhythmia may beperformed to enable a delayed ATP to be canceled when the detectedtachyarrhythmia is determined to self-terminate or has a non-steadyrate.

FIG. 10 is a schematic diagram of one example of a transvenous ICDsystem 400 in which aspects disclosed herein for controlling ATP therapymay be implemented. The IMD system 400 of FIG. 10 includes an ICD 410coupled to a patient's heart 402 via transvenous electrical leads 406,411, and 416. ICD 410 includes a connector block 412 that may beconfigured to receive the proximal ends of a right ventricular (RV) lead416, a right atrial (RA) lead 411 and a coronary sinus (CS) lead 406,which are advanced transvenously for positioning electrodes for sensingand stimulation in three or all four heart chambers.

RV lead 416 is positioned such that its distal end is in the rightventricle for sensing RV cardiac signals and delivering pacing orshocking pulses in the right ventricle. For these purposes, RV lead 416is equipped with pacing and sensing electrodes shown as a ring electrode430 and a tip electrode 428. In some examples, tip electrode 428 is anextendable helix electrode mounted retractably within an electrode head429. RV lead 416 is further shown to carry defibrillation electrodes 424and 426, which may be elongated coil electrodes used to deliver highvoltage CV/DF pulses. Defibrillation electrode 424 may be referred toherein as the “RV defibrillation electrode” or “RV coil electrode”because it may be carried along RV lead 416 such that it is positionedsubstantially within the right ventricle when distal pacing and sensingelectrodes 428 and 430 are positioned for pacing and sensing in theright ventricle. Defibrillation electrode 426 may be referred to hereinas a “superior vena cava (SVC) defibrillation electrode” or “SVC coilelectrode” because it may be carried along RV lead 416 such that it ispositioned at least partially along the SVC when the distal end of RVlead 416 is advanced within the right ventricle.

Each of electrodes 424, 426, 428 and 430 are connected to a respectiveinsulated conductors extending within the body of lead 416. The proximalend of the insulated conductors are coupled to corresponding connectorscarried by proximal lead connector 414, e.g., a DF-4 connector, at theproximal end of lead 416 for providing electrical connection to ICD 410.It is understood that although ICD 410 is illustrated in FIG. 10 as amulti-chamber device coupled to RA lead 411 and CS lead 406 in additionto RV lead 416, ICD 410 may be configured as a single chamber devicecoupled only to RV lead 416 and may be configured to perform thetechniques disclosed herein using electrodes 424, 426, 428 and/or 430(and in some examples housing 415) for receiving cardiac electricalsignals for delivering electrical stimulation therapy, including ATPtherapy.

RA lead 411 is positioned such that its distal end is in the vicinity ofthe right atrium and the superior vena cava. Lead 411 is equipped withpacing and sensing electrodes 417 and 421 shown as a tip electrode 417,which may be an extendable helix electrode mounted retractably withinelectrode head 419, and a ring electrode 421 spaced proximally from tipelectrode 417. The electrodes 417 and 421 provide sensing and pacing inthe right atrium and are each connected to a respective insulatedconductor with the body of RA lead 411. Each insulated conductor iscoupled at its proximal end to connector carried by proximal leadconnector 413.

CS lead 406 is advanced within the vasculature of the left side of theheart via the coronary sinus and a cardiac vein 418. CS lead 406 isshown in the embodiment of FIG. 10 as having one or more electrodes 408that may be used in combination with either RV coil electrode 420 or theSVC coil electrode 423 for delivering electrical shocks forcardioversion and defibrillation therapies. In other examples, coronarysinus lead 406 may also be equipped with one or more electrodes 408 foruse in delivering pacing and/or for sensing cardiac electrical signalsin the left chambers of the heart, i.e., the left ventricle and/or theleft atrium. The one or more electrodes 408 are coupled to respectiveinsulated conductors within the body of CS lead 406, which providesconnection to the proximal lead connector 404.

The RA pacing and sensing electrodes 417 and 421 and the RV pacing andsensing electrodes 428 and 430 may be used as bipolar pairs, commonlyreferred to as a “tip-to-ring” configuration for sensing cardiacelectrical signals and delivering low voltage pacing pulses, e.g., forATP delivery following tachyarrhythmia detection as described herein.Further, RV tip electrode 428 may be selected with a coil electrode 424or 426 to be used as an integrated bipolar pair, commonly referred to asa “tip-to-coil” configuration for sensing cardiac electrical signals.ICD 410 may, for example, select one or more sensing electrode vectorsincluding a tip-to-ring sensing vector between electrodes 428 and 430and a tip-to-coil sensing vector, e.g., between RV tip electrode 428 andSVC coil electrode 426, between RV tip electrode 428 and RV coilelectrode 424, between RV ring electrode 430 and SVC coil electrode 426or between RV ring electrode 430 and RV coil electrode 424 In somecases, any of electrodes 408, 417, 421, 424, 426, 428 or 430 may beselected by ICD 410 in a unipolar sensing configuration with the ICDhousing 415 serving as the indifferent electrode, commonly referred toas the “can” or “case” electrode. It is recognized that numerous sensingand electrical stimulation electrode vectors may be available using thevarious electrodes carried by one or more of leads 406, 415 and 416coupled to ICD 410, and ICD 410 may be configured to selectively coupleone or more sensing electrode vectors to sensing circuitry enclosed byhousing 415, e.g., sensing circuitry including one or more amplifiers,filters, rectifiers, comparators, sense amplifiers, analog-to-digitalconvertors and/or other circuitry configured to acquire a cardiacelectrical signal for use in detecting cardiac arrhythmias, as generallydescribed above in conjunction with FIG. 5.

Housing 415 encloses internal circuitry generally corresponding to thevarious modules and components described in conjunction with FIG. 5 forsensing cardiac signals, detecting tachyarrhythmia, and controllingtherapy delivery. ICD 410 may be configured to detect atrialtachyarrhythmia and ventricular tachyarrhythmia and may be capable ofdelivering both atrial ATP and ventricular ATP. As such, the methodsdisclosed herein for delaying an ATP therapy after tachyarrhythmiadetection and determining if ATP delivery criteria are met may beapplied to atrial tachyarrhythmia detection and atrial ATP. In someexamples, the ICD housing 415 may serve as a subcutaneous defibrillationelectrode in combination with one or more of the coil electrodes 424 or426 for delivering CV/DF shocks. It is recognized that alternative leadsystems may be substituted for the three lead system illustrated in FIG.10. While a particular multi-chamber ICD and transvenous lead system 400is illustrated in FIG. 10, methodologies described herein for detectingtachyarrhythmia and controlling ATP delivery based on ATP deliverycriteria may adapted for use with any single chamber, dual chamber, ormulti-chamber transvenous ICD or pacemaker system.

FIG. 11A is a schematic diagram of an implantable medical device system500 that includes extra-cardiovascular ICD 14 coupled toextra-cardiovascular lead 16 extending in a substernal position, asshown in FIG. 2A, and an intra-cardiac pacemaker 512. In some examples,intra-cardiac pacemaker 512 may be configured to deliver cardiac pacingpulses, including ATP pulses, via housing-based electrodes 514 and 516.Intra-cardiac pacemaker 512 may be configured to detect ventriculartachyarrhythmia and deliver ATP. As such, intra-cardiac pacemaker 512may include a sensing module, control module and therapy delivery modulehaving a LV therapy module, which may generally correspond to LV therapymodule 85 described in conjunction with FIG. 5. The control module maybe configured to detect tachyarrhythmia from cardiac signals received bythe sensing module in the manner described above in conjunction withFIG. 5. The control module may be configured to confirm that ATPdelivery criteria are met before controlling the LV therapy deliverymodule to deliver ATP pulses. Intra-cardiac pacemaker 512 may generallycorrespond to the intra-cardiac pacemaker disclosed in U.S. Pat. No.9,468,766 (Sheldon, et al.), incorporated herein by reference in itsentirety. In some examples, ICD 14 may be omitted from system 500 suchthat intra-cardiac pacemaker 512 is provided for detecting cardiacrhythms and delivering cardiac pacing as needed, including ATP therapyusing the techniques disclosed herein.

ICD 14 may be included in system 500 to provide high voltagecardioversion/defibrillation therapies as needed. In some examples, ICD14 performs tachyarrhythmia detection, and pacemaker 512 may be atriggered pacemaker that is configured to receive a trigger signal fromICD 14 for controlling the timing of ATP pulses. In this case, pacemaker512 may or may not be configured to detect tachyarrhythmia. ICD 14 maydetect tachyarrhythmia and generate a trigger signal that is passed tointra-cardiac pacemaker 512 to control the timing of ATP pulsesdelivered by intra-cardiac pacemaker 512. In some examples, the triggersignal is passed directly from ICD 14 to pacemaker 512, e.g., usingwireless telemetry signals or tissue conductance communication.

In other examples, as shown in FIG. 11B, IMD system 500 includes atrigger signal emitting device 520. Trigger signal emitting device 520may be coupled to ICD 14 via a control signal line 522 for receiving acontrol signal from ICD 14. The control signal causes trigger signalemitting device 520 to emit a trigger signal that is received byintra-cardiac pacemaker 512. The trigger signal may be a tissueconductance communication signal, an acoustical signal, an opticalsignal or other wireless signal. Upon receiving a trigger signal,pacemaker 512 is triggered to deliver one or more pacing pulses. Whiletrigger signal emitting device 520 is shown as a separate device coupledto ICD 14 via a control signal line 522, trigger signal emitting device520 may be a wireless device configured to receive wireless controlsignals from ICD 14 or may be incorporated within ICD housing 15.Implantable medical device system 500 may generally correspond to any ofthe triggered pacing systems disclosed in pending U.S. Pat. No.9,669,224 (Carney, et al.), incorporated herein by reference in itsentirety.

FIG. 12 is a flow chart 600 of a method for controlling ATP therapy byan implantable medical device system according to another example. Invarious examples, the method of flow chart 600 may be performed by ICD14 of FIGS. 1A-2C and FIGS. 11A and 11B, by ICD 410 of FIG. 10, by theintracardiac pacemaker 512 of FIG. 11A or 11B, or by a combination ofICD 14 and pacemaker 512 in the system 500 of FIGS. 11A and 11B. Inthese examples, either a HV therapy module 83 or a LV therapy module 85may be used to deliver the ATP therapy, e.g., HV therapy module 83 or LVtherapy module 85 shown in FIG. 5. A LV therapy module 85 may includeone or more holding capacitors having a lower capacitance and a lowervoltage rating than HV capacitor 210 of HV therapy module 83 since theLV therapy module 85 included in the IMD system for delivering ATPpulses is not configured to generate high voltage CV/DF shock pulses.The maximum voltage amplitude of a pacing pulse generated by the LVtherapy module 85 may be 8 to 10 V.

In these examples, adjustment of the HV capacitor charge to the pacingvoltage amplitude may not be required. The time to charge a LV therapymodule holding capacitor is generally minimal such that an ATP pulse canbe delivered at an ATP pacing interval following the tachyarrhythmiadetection. However, an ICD system operating according to the techniquesdisclosed herein delays an enabled ATP therapy and determines if ATPdelivery criteria are met during the ATP therapy delay, even if thetherapy delivery module is ready to deliver the ATP therapy sooner thanthe ATP therapy delay period. This ATP therapy delay may allow thedetected tachyarrhythmia to self-terminate, without requiring a therapy.

At block 602, cardiac electrical signal(s) are monitored for detecting atachyarrhythmia using the techniques described above or in any of theincorporated references. The illustrative examples described hereingenerally relate to detecting ventricular tachyarrhythmia and deliveringventricular ATP. It is recognized, however, that the method of FIG. 12and other methods disclosed herein may correspond to detecting atrialtachyarrhythmia and controlling atrial ATP therapy delivery, e.g., usingsystem 400 of FIG. 10 or intra-cardiac pacemaker 512 of FIG. 11Bpositioned in an atrial chamber. If tachyarrhythmia is detected at block604, control module 80 determines if ATP therapy is enabled for thedetected tachyarrhythmia according to programmed therapies stored inmemory 82. If ATP is not enabled, control module 80 may control thetherapy delivery module 84 to deliver a shock therapy at block 608 whencardioversion/defibrillation shock capabilities are included.

If ATP is enabled at block 605, control module 80 delays the enabled ATPtherapy at block 610. In IMD system 10 or 500, ICD 14 may be programmedto deliver ATP using the HV therapy module 83. Control module 80 maywait before delivering an enabled ATP therapy after tachyarrhythmiadetection by controlling the HV therapy module 83 to prepare the HVcapacitor for delivering the ATP therapy, e.g., as described above inconjunction with FIGS. 7 and 8. The time required for adjusting the HVcapacitor to within a tolerance of the pacing voltage amplitude may bethe ATP therapy delay period, which may be a variable time perioddepending on the time required to adjust the HV capacitor charge.

In other examples, control module 80 may wait to deliver the ATP atblock 610 for a predetermined number of sensed cardiac events, e.g., apredetermined number of sensed R-waves and/or P-waves, or apredetermined number of sensed cardiac event intervals, e.g. apredetermined number of RR intervals or PP intervals. In other examples,control module 80 may wait to deliver ATP for a predetermined delayperiod set as a fixed time interval, e.g., 1 second, 2 seconds, 3seconds, 5 seconds or other predetermined time interval. In any of theseexamples, IMD system 10, 400 or 500 may be programmed to deliver the ATPfrom a LV therapy module, such as LV therapy module 85. Preparation ofthe HV capacitor may not be required during the ATP delay period.

During the ATP delay period, control module 80 may determine sensedevent intervals and/or sensed event morphology at block 612. Asdescribed above in conjunction with FIGS. 7 and 8, RRIs may bedetermined and compared to ATP delivery criteria at block 616 bycomparing the RRIs to a synchronization interval established by thecontrol module 80. If a predetermined number, percentage or ratio of theRRIs determined during the ATP delay period are less than thesynchronization interval, the ATP delivery criteria are met at block616.

In other examples, the implantable medical device system employing thetechniques of FIG. 12 may be configured to determine PP intervals, PRintervals, RP intervals or other sensed cardiac event intervals fordetermining if the ATP delivery criteria are met at block 616. Forexample, the transvenous ICD system of FIG. 10 may be configured tosense atrial signals from the RA lead 411 and use atrial signals indetermining if ATP delivery criteria are met at block 616. The ATPdelivery criteria may be directed to control delivery of atrial ATPand/or ventricular ATP. The tachyarrhythmia detected at block 604 may bea supraventricular tachyarrhythmia or a ventricular tachyarrhythmia. Theenabled ATP therapy (block 605) may be atrial ATP and/or ventricularATP.

If a supraventricular tachyarrhythmia is detected at block 604 andatrial ATP is enabled, the control module may determine PP intervalsbetween consecutively sensed P-waves for comparison to a synchronizationinterval at block 616. If a ventricular tachyarrhythmia is detected atblock 604, the control module may determine RR intervals, PR intervals,RP intervals, or a combination of RR, PR and/or RP intervals forcomparison to criteria for delivering ATP at block 616. Such criteriamay generally require that a predetermined percentage or portion of thesensed event intervals be less than a synchronization interval and/orwithin an interval range indicating a steady rate of the detectedtachyarrhythmia. If PR and/or RP intervals are determined to be regularand stable, atrial ATP delivery criteria may be met but ventricular ATPdelivery criteria may be unmet since regular PR or RP intervals mayindicate supraventricular tachyarrhythmia.

In addition to or alternatively to determining cardiac sensed eventintervals at block 612, it is contemplated that sensed event morphologyfeatures or metrics may be determined at block 612 during the ATP delay.Sensed event morphology and/or sensed event intervals may be compared toATP delivery criteria at block 616. For example, if ventricular ATPtherapy is enabled and ventricular tachyarrhythmia is detected at block604, the morphology of sensed events during the ATP delay may becompared to each other or a morphology template determined prior to thetachyarrhythmia detection or during the tachyarrhythmia detection todetermine if the morphology represents a non-changing morphology duringthe ATP delay and/or since tachyarrhythmia detection.

The ATP delay period may be a variable period that is terminated upondetermining whether ATP delivery criteria are met. Alternatively, theATP delay period may be terminated after a predetermined time interval,number of sensed events or event intervals, or upon completion ofcapacitor preparation for ATP delivery when the HV therapy module 83 isused for ATP delivery. If ATP delivery criteria are met, ATP isdelivered at block 618. Delivery of ATP at block 618 includessynchronizing the first ATP pulse to the most recent sensed event thatresulted in ATP delivery criteria being met or immediately following ATPdelivery criteria being met. The first pulse may be delivered at an ATPinterval that is based on one or more cardiac event intervals determinedduring the ATP delay or the one or more sensed event intervals that letup to the tachyarrhythmia detection at block 604. ATP pulses may begenerated and delivered by the LV pacing circuit of the IMD system,e.g., LV therapy module 85 shown in FIG. 5 or an analogous LV therapymodule included in ICD 410 of FIG. 10 or pacemaker 512 shown in FIG. 11Aor 11B.

In the system of FIG. 11A or 11B, ATP pulses may be delivered byintra-cardiac pacemaker 512. Intra-cardiac pacemaker 512 may include acontrol module that is configured to detect the tachyarrhythmia, delayATP and determine if the ATP delivery criteria are met. Alternatively,intra-cardiac pacemaker 512 may be configured to receive trigger signalsfrom ICD 14 or a trigger signal emitting device 520 for triggeringpacemaker 512 to deliver ATP pulses after ICD 14 determines that ATPdelivery criteria are met. In still another example, ICD 14 may detectthe tachyarrhythmia and transmit a trigger signal to pacemaker 512,directly or via trigger signal emitting device 520, to cause pacemaker512 to initiate an ATP therapy delay period and determine if ATPdelivery criteria are met for making the decision of whether to deliveror cancel ATP after receiving the trigger signal from ICD 14.

If the ATP delivery criteria are not met at block 616, the delayed ATPtherapy is canceled at block 620. After delivering or canceling the ATP,the control module returns to block 602 to continue monitoring thecardiac signal. As such, an IMD system configured to execute an ATPtherapy delay period and ATP delivery confirmation based on ATP deliverycriteria applied to a cardiac signal acquired during the ATP therapydelay period may be implemented in an IMD system that includes one ormore implantable devices. The functions of detecting a tachyarrhythmia,starting an ATP therapy delay period, determining if ATP deliverycriteria are met, and delivering (or canceling) the ATP therapy may beperformed by a single device or distributed across more than oneimplantable medical device included in the IMD system.

FIG. 13 is a flow chart 700 of a method for controlling ATP therapyaccording to yet another example. Upon detecting a tachyarrhythmia atblock 702, control module 80 may determine if ATP is enabled fordelivery from the HV therapy module 83 at block 704. If not, controlmodule 80 may deliver therapy at block 706 according to a programmedmenu of therapies, which may include ATP delivered from the LV therapymodule 85 and/or a shock therapy from the HV therapy module 83. ATP maybe delivered from the LV therapy module 85 at block 706 without an ATPdelay period. If ATP therapy is not enabled for the detectedtachyarrhythmia, e.g., according to a programmed sequence of therapies,a CV/DF shock may be delivered at block 706.

In some cases, a maximum number of delayed ATP therapies may have beencanceled due to ATP delivery criteria not being reached during an ATPdelay period. If ATP is enabled to be delivered from the HV therapymodule 83, but ATP has been canceled a maximum number of times, controlmodule 80 may advance to deliver the next therapy at block 706, e.g., ashock therapy.

If ATP therapy is enabled for delivery from the HV therapy module 83 anda maximum number of canceled ATP therapies has not been reached, controlmodule 80 starts the ATP delay period at block 708 and starts chargingthe HV capacitor at block 710. In this example, charging of the HVcapacitor is performed for a predetermined charge time period. In somecases, the HV capacitor may reach a programmed ATP pacing pulseamplitude prior to the expiration of the predetermined charge timeperiod but is held at the programmed pacing pulse amplitude for the ATPdelay period. In one example, the capacitor charge time period is onesecond. In other examples, the capacitor charge time period may be morethan one second. The capacitor charge time period may be selected to beat least long enough for the HV capacitor to be charged to theprogrammed pacing voltage amplitude for ATP therapy delivery.

During the ATP delay period, control module 80 may monitor for slowingevents at block 712. A slowing event may be an RRI that is greater thanthe synchronization interval (established according to any of thetechniques described above), a delivered ventricular pacing pulse or anexpired ventricular pacing escape interval, e.g., during an OVO pacingmode. If a slowing event occurs during the capacitor charge time period,the slowing event may be counted by control module 80, but charging ofthe HV capacitor and maintenance of the HV capacitor charge at thepacing voltage amplitude continues for the predetermined fixed chargetime period.

Upon expiration of the capacitor charge time period at block 714, thecontrol module 80 waits for the next ventricular event at block 716. Ifthe earliest ventricular event after the predetermined charge timeperiod expires is a sensed R-wave, the RRI ending with the sensed R-waveis compared to the synchronization interval at block 718. If the RRI isless than or equal to the synchronization interval, the ventricularevent is classified as a tachyarrhythmia event at block 720.

Control module 80 determines if a required number of tachyarrhythmiaevents have been detected at block 722, after the charge time periodexpired. In one example, only a single tachyarrhythmia event after thecharge time period expires is required for ATP delivery criteria to bemet. ATP is delivered from the HV therapy module 83 at block 724,synchronized to the first sensed R-wave after the charge time periodexpires. In other examples, two or more tachyarrhythmia events, e.g.,two or more R-waves occurring at RRIs that are less than thesynchronization interval, are required in order for ATP deliverycriteria to be met before delivering ATP at block 724. If more than onetachyarrhythmia events are required for delivering the delayed ATP, theprocess returns to block 716 to wait for the next V event.

If the first ventricular event after the charge time period expires is asensed R-wave occurring at an RRI that is greater than thesynchronization interval, “no” branch of block 718, the event isclassified as a slowing event at block 726. In some instances, a pacingescape interval may expire after the charge time period expires with nosensed R-wave. In this case, the first V event at block 716 may be adelivered ventricular pacing pulse. The ventricular event interval, anexpired pacing escape interval, is greater than the synchronizationinterval at block 718, and a slowing event is detected at block 726. Inan OVO pacing mode, no ventricular pacing pulse may be delivered at theexpiration of a ventricular pacing escape interval but the expiredpacing escape interval may be treated as an event interval that isgreater than the synchronization interval and be detected as a slowingevent at block 726.

Control module 80 determines at block 728 if a threshold number ofslowing events have been counted since the ATP delay period was started.In some examples, control module 80 cancels the ATP therapy at block 730in response to a single slowing event after the charge time periodexpires. In other examples, at least two slowing events are required atblock 728 in order to cancel the ATP therapy at block 730. One or moreslowing events may be detected during the charge time period with atleast one slowing event after the charge time period expires. Forinstance, if at least one slowing event occurs during the charge timeperiod and the first ventricular event after the charge time periodexpires is a slowing event, the ATP cancel threshold is reached at block728. In other instances, if no slowing event occurs during the chargetime period, two slowing events after expiration of the charge timeperiod are required before canceling the ATP therapy at block 730.

An ATP therapy may be canceled multiple times before being deliveredafter at least one tachyarrhythmia event occurs after tachyarrhythmiadetection and after the charge time period expires. After ATP isdelivered at block 724, the tachyarrhythmia may be redetected at block702. Control module 80 may advance to the next therapy in a sequence ofprogrammed therapies enabled for treating the detected tachyarrhythmiaif the tachyarrhythmia is redetected after the first therapy isdelivered. The next therapy may be a second attempt of the same ATPsequence, a different ATP sequence, or a shock therapy. If the nexttherapy attempted after the tachyarrhythmia episode is redetected is thesame or a different ATP therapy sequence using the HV therapy module 83,the method of FIG. 13 may be repeated to deliver the next ATP therapyafter an ATP delay period as long as the threshold number of slowingevents is not reached during the ATP delay period. A maximum number ofcanceled ATP therapies may be allowed. If the maximum number of canceledATP therapies is reached, a CV/DF shock may be delivered at block 705upon redetection of the tachyarrhythmia episode at block 702.

In the example of FIG. 13, ATP therapy enabled from the HV therapymodule 83 is delayed by starting an ATP delay period, starting a fixedHV capacitor charge time, and verifying that at least the first sensedcardiac event after the fixed HV capacitor charge time is atachyarrhythmia event. The ATP therapy delay period is terminated andthe delayed ATP therapy is delivered in response to a threshold number,e.g., one or more, tachyarrhythmia events being detected after the fixedHV capacitor charge time expires. The ATP therapy delay period may beterminated and the delayed ATP therapy may be canceled in response to athreshold number, e.g., two or more, slowing events being detectedduring and/or after the fixed HV capacitor charge time expires. Aslowing event is detected in response to each RRI greater than anestablished synchronization interval and in response to each expiredventricular pacing escape interval that occurs during the fixedcapacitor charge time and/or after the fixed capacitor charge timeexpires.

Thus, an IMD system and method for controlling and delivering ATPtherapy have been presented in the foregoing description with referenceto specific embodiments. In other examples, various methods describedherein may include steps performed in a different order or combinationthan the illustrative examples shown and described herein. It isappreciated that various modifications to the referenced embodiments maybe made without departing from the scope of the disclosure and thefollowing claims.

1. An implantable medical device system comprising: a sensing moduleconfigured to receive a cardiac electrical signal from a patient's heartvia a sensing electrode vector and sense cardiac events from the cardiacelectrical signal; a therapy delivery module configured to generatepulses for delivering an anti-tachycardia pacing (ATP) therapy to thepatient's heart via a pacing electrode vector; and a control modulecoupled to the sensing module and the therapy delivery module andconfigured to: detect a tachyarrhythmia from the cardiac electricalsignal; start an ATP therapy delay period to delay the ATP therapy inresponse to detecting the tachyarrhythmia; determine whether ATPdelivery criteria are satisfied based on the cardiac electrical signalreceived by the sensing module during the ATP therapy delay period;control the therapy delivery module to deliver the delayed ATP therapyin response to the ATP delivery criteria being satisfied; and cancel thedelayed ATP therapy in response to the ATP delivery criteria not beingsatisfied.
 2. The system of claim 1, wherein the control module isconfigured to determine whether the ATP delivery criteria are satisfiedby: determining sensed cardiac event intervals during the ATP therapydelay period, each sensed cardiac event interval being determined as atime interval between a pair of consecutively sensed cardiac eventssensed by the sensing module; comparing the sensed cardiac eventintervals determined during the ATP therapy delay period to asynchronization interval; and determining that the ATP delivery criteriaare satisfied in response to a threshold number of the sensed cardiacevent intervals determined during the ATP therapy delay period beingless than the synchronization interval.
 3. The system of claim 2,wherein the control module is further configured to: detect thetachyarrhythmia in response to a predetermined number of sensed eventintervals determined from the cardiac electrical signal being less thana tachyarrhythmia detection interval; and establish the synchronizationinterval based on at least one of the tachyarrhythmia detection intervaland/or at least a portion of the predetermined number of sensed eventintervals less than the tachyarrhythmia detection interval.
 4. Thesystem of claim 2, wherein the control module is further configured todetermine that the ATP delivery criteria are met by: detecting a steadyrate of the detected tachyarrhythmia during the ATP therapy delay periodin response to sensed cardiac event intervals determined during the ATPtherapy delay period being within an interval range.
 5. The system ofclaim 1, wherein: the therapy delivery module comprises a high voltagetherapy module comprising: a high voltage capacitor chargeable to ashock voltage amplitude; and a high voltage charging circuit configuredto charge the first capacitor to the shock voltage amplitude fordelivering a cardioversion/defibrillation shock pulse; and the controlmodule is configured to: in response to detecting the tachyarrhythmia,control the high voltage therapy module to adjust a charge of the highvoltage capacitor to a pacing voltage amplitude during the ATP therapydelay period, the pacing voltage amplitude less than the shock voltageamplitude; determine if the capacitor charge is within a tolerance ofthe pacing voltage amplitude; and in response to determining that thecapacitor charge is within the tolerance of the pacing voltageamplitude, determine if the ATP delivery criteria are met.
 6. The systemof claim 5, wherein the control module is configured to adjust the highvoltage capacitor charge to within the tolerance of the pacing voltageamplitude by dumping a portion of a residual charge stored on the highvoltage capacitor through a non-therapeutic load.
 7. The system of claim5, wherein the control module is configured to adjust the high voltagecapacitor charge to within the tolerance of the pacing voltage amplitudeby controlling the high voltage charging circuit to charge the highvoltage capacitor.
 8. The system of claim 5, wherein the control moduleis further configured to: determine sensed cardiac event intervalsduring the ATP therapy delay period, each sensed cardiac event intervalbeing determined as a time interval between a pair of consecutivelysensed cardiac events sensed by the sensing module; detect a non-steadyrate of the detected tachyarrhythmia during the ATP therapy delay periodby determining that the sensed cardiac event intervals do not remainwithin an interval range during the ATP delay period; terminate theadjusting of the capacitor charge in response to the non-steady rate ofthe detected tachyarrhythmia; and cancel the ATP therapy in response todetecting the non-steady rate.
 9. The system of claim 5, wherein thecontrol module is configured to control the high voltage therapy moduleto hold the high voltage capacitor charge at the pacing voltageamplitude in response to the ATP delivery criteria not being met. 10.The system of claim 9, wherein the control module is further configuredto: redetect the tachyarrhythmia after canceling the ATP therapy;determine that the redetected tachyarrhythmia has accelerated; andcontrol the high voltage therapy module to: charge the high voltagecapacitor from the pacing voltage amplitude to the shock voltageamplitude in response to the tachyarrhythmia being accelerated; anddeliver a cardioversion/defibrillation shock pulse having the shockvoltage amplitude.
 11. The system of claim 5, wherein the control moduleis further configured to: compare a charge of the high voltage capacitorto charge adjustment criteria in response to detecting thetachyarrhythmia; and cancel the ATP therapy in response to the chargeadjustment criteria not being met.
 12. The system of claim 1, whereinthe control module is further configured to: detect a non-steady rate ofthe detected tachyarrhythmia during the ATP therapy delay period; cancelthe delayed ATP therapy in response to the detected non-steady rate;determine that ATP therapy has been canceled a threshold number oftimes; and adjust tachyarrhythmia detection criteria used for detectingthe tachyarrhythmia in response to the ATP therapy being canceled thethreshold number of times.
 13. The system of claim 1, wherein thecontrol module is configured to delay the ATP therapy for one of apredetermined time interval, a predetermined number of sensed cardiacevents, or capacitor charge time.
 14. The system of claim 1 furthercomprising an intra-cardiac pacemaker including the therapy deliverymodule; wherein the control module controls the intra-cardiac pacemakerto deliver the ATP therapy in response to the ATP therapy deliverycriteria being satisfied.
 15. The system of claim 1, comprising ahousing enclosing the sensing module, the therapy delivery module andthe control module, the housing comprising a connector block forreceiving an extra-cardiovascular lead carrying at least one electrodeof the pacing electrode vector.
 16. The system of claim 1, comprising ahousing enclosing the sensing module, the therapy delivery module andthe control module, the housing comprising a connector block forreceiving a transvenous lead carrying at least one electrode of thepacing electrode vector.
 17. The system of claim 1, wherein the controlmodule is further configured to: charge a capacitor of the therapydelivery module during the ATP therapy delay period during a fixedcapacitor charge time period; classify a cardiac event sensed by thesensing module after the fixed capacitor charge time period as one of aslowing event or a tachyarrhythmia event; determine that the ATPdelivery criteria are satisfied in response to the cardiac event beingclassified as a tachyarrhythmia event; and determine that the ATPdelivery criteria are not satisfied in response to the cardiac eventbeing classified as a slowing event.
 18. The system of claim 17, whereinthe control module is configured to detect a slowing event during theATP therapy delay period in response to each sensed cardiac eventinterval being greater than a synchronization interval and each expiredcardiac pacing interval.
 19. The system of claim 18, wherein the controlmodule is further configured to determine that the ATP delivery criteriaare not satisfied in response to detecting a threshold number of slowingevents during the ATP therapy delay period.
 20. A method comprising:detecting a tachyarrhythmia from a cardiac electrical signal receivedfrom a patient's heart; starting an anti-tachycardia pacing (ATP)therapy delay period to delay an ATP therapy in response to detectingthe tachyarrhythmia; determining whether ATP delivery criteria aresatisfied based on the cardiac electrical signal received during the ATPtherapy delay period; delivering the delayed ATP therapy in response tothe ATP delivery criteria being satisfied; and canceling the delayed ATPtherapy in response to the ATP delivery criteria not being satisfied.21. The method of claim 20, wherein determining if the ATP deliverycriteria are satisfied comprises: determining sensed cardiac eventintervals during the ATP therapy delay period, each sensed cardiac eventinterval being determined as a time interval between a pair ofconsecutively sensed cardiac events; comparing the determined sensedcardiac event intervals to a synchronization interval; and determiningthat the ATP delivery criteria are satisfied in response to a thresholdnumber of the determined sensed cardiac event intervals being less thanthe synchronization interval.
 22. The method of claim 21, furthercomprising: detecting the tachyarrhythmia in response to a predeterminednumber of sensed event intervals determined from the cardiac electricalsignal being less than a tachyarrhythmia detection interval; andestablishing the synchronization interval based on at least one of thetachyarrhythmia detection interval and/or at least a portion of thepredetermined number of sensed event intervals less than thetachyarrhythmia detection interval.
 23. The method of claim 21, whereindetermining that the ATP delivery criteria are met further comprises:detecting a steady rate of the detected tachyarrhythmia during the ATPtherapy delay period in response to sensed cardiac event intervalsdetermined during the ATP therapy delay period being within an intervalrange.
 24. The method of claim 20, further comprising: adjusting acharge of a high voltage capacitor to a pacing voltage amplitude duringthe ATP therapy delay period, the high voltage capacitor chargeable to ashock voltage amplitude for delivering a cardioversion/defibrillationshock pulse, the pacing voltage amplitude less than the shock voltageamplitude; determining if the high voltage capacitor charge is within atolerance of the pacing voltage amplitude; and in response to thecapacitor charge being adjusted to within the tolerance of the pacingvoltage amplitude, determining if the ATP delivery criteria are met. 25.The method of claim 24, wherein adjusting the high voltage capacitorcharge to within the tolerance of the pacing voltage amplitude comprisesdumping a portion of a residual charge stored on the high voltagecapacitor through a non-therapeutic load.
 26. The method of claim 24,wherein adjusting the high voltage capacitor charge to within thetolerance of the pacing voltage amplitude comprises charging the highvoltage capacitor.
 27. The method of claim 24, further comprising:determining sensed cardiac event intervals during the ATP therapy delayperiod, each sensed cardiac event interval being determined as a timeinterval between a pair of consecutively sensed cardiac events;detecting a non-steady rate of the detected tachyarrhythmia during theATP therapy delay period by determining that the sensed cardiac eventintervals do not remain within an interval range during the ATP delayperiod; terminating the adjusting of the capacitor charge in response tothe non-steady rate of the detected tachyarrhythmia; and canceling theATP therapy in response to detecting the non-steady rate.
 28. The methodof claim 24, further comprising holding the high voltage capacitorcharge at the pacing voltage amplitude in response to the ATP deliverycriteria not being met.
 29. The method of claim 28, further comprising:redetecting the tachyarrhythmia after canceling the ATP therapy;determining that the redetected tachyarrhythmia has accelerated;charging the high voltage capacitor from the pacing voltage amplitude tothe shock voltage amplitude in response to the tachyarrhythmia beingaccelerated; and delivering a cardioversion/defibrillation shock pulsehaving the shock voltage amplitude.
 30. The method of claim 24, furthercomprising: comparing a charge of the high voltage capacitor to chargeadjustment criteria in response to detecting the tachyarrhythmia; andcanceling the ATP therapy in response to the charge adjustment criterianot being met.
 31. The method of claim 20, further comprising: detectinga non-steady rate of the detected tachyarrhythmia during the ATP therapydelay period; canceling the delayed ATP therapy in response to the rateof the detected tachyarrhythmia not being steady during the ATP delayperiod; determining that ATP therapy has been canceled a thresholdnumber of times; and adjusting tachyarrhythmia detection criteria usedfor detecting the tachyarrhythmia in response to ATP therapy beingcanceled the threshold number of times.
 32. The method of claim 20,further comprising delaying the ATP therapy for one of a predeterminedtime interval, a predetermined number of sensed cardiac events, or acapacitor charge time.
 33. The method of claim 20, further comprisingcontrolling an intra-cardiac pacemaker to deliver the ATP therapy inresponse to the ATP therapy delivery criteria being satisfied.
 34. Themethod of claim 20, further comprising delivering the ATP therapy via atleast one electrode carried by an extra-cardiovascular lead.
 35. Themethod of claim 20, further comprising: charging a capacitor of thetherapy delivery module during the ATP therapy delay period during afixed capacitor charge time period; classifying a sensed cardiac eventafter the fixed capacitor charge time period as one of a slowing eventor a tachyarrhythmia event; and determining that the ATP deliverycriteria are satisfied in response to the cardiac event being classifiedas a tachyarrhythmia event; and determining that the ATP deliverycriteria are not satisfied in response to the cardiac event beingclassified as a slowing event.
 36. The method of claim 32, furthercomprising detecting a slowing event during the ATP therapy delay periodin response to each sensed cardiac event interval being greater than asynchronization interval and each expired cardiac pacing interval. 37.The method of claim 36, further comprising determining that the ATPdelivery criteria are not satisfied in response to detecting a thresholdnumber of slowing events during the ATP therapy delay period.
 38. Anon-transitory, computer-readable storage medium comprising a set ofinstructions which, when executed by a processor cause the processor to:detect a tachyarrhythmia from a cardiac electrical signal received froma patient's heart; start an anti-tachycardia pacing (ATP) therapy delayperiod to delay an ATP therapy in response to detecting thetachyarrhythmia; determine whether ATP delivery criteria are satisfiedbased on the cardiac electrical signal received during the ATP therapydelay period; deliver the delayed ATP therapy in response to the ATPdelivery criteria being satisfied; and cancel the delayed ATP therapy inresponse to the ATP delivery criteria not being satisfied.